Mutation in IDH1 and IDH2

IDH1/2 mutation

Active trials
149
Recruiting now
80
FDA approvals
8
EU approvals
3
Companies
24

Trials that select patients by IDH1/2 mutation or a broader group that includes it, the therapies approved for it, and who is developing what. Seen most often in AML, glioma, cholangiocarcinoma, MDS, chondrosarcoma.

Added in v3.0. Matches on this page are included in our accuracy checks (about 9 in 10 correct across all pages) but have had fewer checks than the original pages. Every trial shows the words that matched.

Trials as of 2026-10-27. Follow this page. .

Since the last update 2026-10-20 to 2026-10-27

New trials 1

Active trials by phase
Early Phase 1: 4 active trialsEarly 14Phase 1: 34 active trials134Phase 1/2: 14 active trials1/214Phase 2: 61 active trials261Phase 2/3: 1 active trials2/31Phase 3: 20 active trials320Phase 4: 2 active trials42N/A: 13 active trialsNo phase13
Trials started per year (2026 so far)
2010: 0 trials started20102011: 1 trials started2012: 0 trials started2013: 1 trials started2014: 4 trials started2015: 11 trials started20152016: 5 trials started2017: 9 trials started2018: 16 trials started2019: 19 trials started2020: 19 trials started20202021: 12 trials started2022: 14 trials started2023: 18 trials started2024: 18 trials started2025: 26 trials started262026: 19 trials started192026

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Results side by side

The pivotal trials behind the approvals below, on one scale. Trials differ in patients, earlier treatment and comparator, so this is a map of the evidence, not a ranking.

Randomised trials: hazard ratio for progression or relapse Point and 95% confidence interval, log scale; left of 1 favours the approved therapy.
AML
ivosidenib + azacitidine AGILE (AG120-C-009), vs placebo + azacitidine EFS 0.35 (0.17-0.72)
cholangiocarcinoma
ivosidenib ClarIDHy, vs placebo PFS 0.37 (0.25-0.54)
glioma (grade 2)
vorasidenib INDIGO, vs placebo PFS 0.39 (0.27-0.56)
TherapyTumourUnited StatesEuropean Union
enasidenib
FDA, 2017
relapsed or refractory, IDH2 mutation FDA approval 01/08/2017; companion test Abbott RealTime IDH2 Assay. Boxed warning: differentiation syndrome. Source
Idhifaenasidenib page
AML Approved 2017 Not approved

AG221-C-001 single-arm, 199 patients
CR+CRh 23%Lasting 8.2 months

Trial details and side effects
Patients
relapsed or refractory IDH2-mutant AML (NCT01915498)
Most common side effects
nausea, vomiting, diarrhoea, raised bilirubin, decreased appetite
Notes
FDA approval as reported by ESMO (2017); differentiation syndrome in 14%.
Source
US approval report
ivosidenib with azacitidine
FDA, 2022
newly diagnosed, susceptible IDH1 mutation, age >=75 or unfit for intensive chemotherapy FDA approval 25/05/2022. Source
EU (EMA), 2023
newly diagnosed, IDH1 R132 mutation, not eligible for standard induction chemotherapy EU marketing authorisation 04/05/2023. Source
Tibsovoivosidenib page
AML Approved 2022 Approved 2023

AGILE (AG120-C-009) vs placebo + azacitidine, 72 vs 74 patients
EFS HR 0.35 (0.17-0.72)CR 47% vs 15%OS 24.0 months vs 7.9 months, HR 0.44 (0.27-0.73)

Trial details and side effects
Patients
newly diagnosed IDH1-mutant AML unfit for intensive chemotherapy (NCT03173248)
Most common side effects
diarrhoea, fatigue, oedema, nausea, vomiting, decreased appetite, leukocytosis, arthralgia, dyspnoea, abdominal pain, mucositis, rash, QT prolongation, differentiation syndrome
Notes
FDA approval summary (2022); side effects are those in 25% or more of patients across ivosidenib trials.
Source
FDA approval summary
ivosidenib
FDA, 2018
relapsed or refractory, susceptible IDH1 mutation FDA approval 20/07/2018; companion test Abbott RealTime IDH1 Assay. Boxed warning: differentiation syndrome. Source
FDA, 2019
newly diagnosed, susceptible IDH1 mutation, age >=75 or unfit for intensive chemotherapy (monotherapy) FDA approval 02/05/2019. Source
Tibsovoivosidenib page
AML Approved 2018 Not approved

AG120-C-001 single-arm, 174 patients
CR+CRh 33% (26-40)Lasting 8.2 months

Trial details and side effects
Patients
relapsed or refractory IDH1-mutant AML (NCT02074839)
Most common side effects
fatigue, leukocytosis, arthralgia, diarrhoea, dyspnoea, oedema, nausea, mucositis, QT prolongation, rash, pyrexia, cough, constipation
Notes
FDA approval summary (2018); side effects are those in 20% or more of patients. Differentiation syndrome can be fatal.
Source
FDA approval summary
olutasidenib
FDA, 2022
relapsed or refractory, susceptible IDH1 mutation FDA approval 01/12/2022; companion test Abbott RealTime IDH1 Assay. Boxed warning: differentiation syndrome. Source
Rezlidhiaolutasidenib page
AML Approved 2022 Not approved

2102-HEM-101 single-arm, 147 patients
CR+CRh 35% (27-43)Lasting 25.9 months

Trial details and side effects
Patients
relapsed or refractory IDH1-mutant AML (NCT02719574)
Most common side effects
nausea, fatigue, arthralgia, constipation, leukocytosis, dyspnoea, fever, rash, mucositis, diarrhoea, raised liver enzymes
Notes
FDA approval summary (2022); side effects are those in 20% or more of patients.
Source
FDA approval summary
ivosidenib
FDA, 2023
relapsed or refractory myelodysplastic syndromes, susceptible IDH1 mutation FDA approval 24/10/2023. Source
Tibsovoivosidenib page
MDS Approved 2023 Not approved

AG120-C-001 (MDS) single-arm, 18 patients
CR 39% (17-64)Lasting not reached

Trial details and side effects
Patients
relapsed or refractory IDH1-mutant MDS (NCT02074839)
Most common side effects
diarrhoea, constipation, mucositis, nausea, arthralgia, fatigue, cough, myalgia, rash
Notes
FDA approval summary (2023). All responses were complete remissions.
Source
FDA approval summary
ivosidenib
FDA, 2021
previously treated, locally advanced or metastatic, IDH1 mutation FDA approval 25/08/2021. Source
EU (EMA), 2023
locally advanced or metastatic, IDH1 R132 mutation, after >=1 prior line of systemic therapy EU marketing authorisation 04/05/2023. Source
Tibsovoivosidenib page
cholangiocarcinoma Approved 2021 Approved 2023

In the US approval report

ClarIDHy vs placebo, 185 randomised
PFS HR 0.37 (0.25-0.54)OS HR 0.79 (0.56-1.12), not significant (about 70% of placebo patients crossed over)

Trial details and side effects
Patients
previously treated IDH1-mutant cholangiocarcinoma (NCT02989857)
Most common side effects
fatigue, nausea, abdominal pain, diarrhoea, cough, decreased appetite, ascites, vomiting, anaemia, rash
Notes
FDA approval as reported by ASCO Post (2021); median PFS was 2.7 vs 1.4 months in the published trial. Side effects are those in 15% or more of patients.
Source
US approval report

In the EU summary (EPAR)

ClarIDHy vs placebo, 187 patients
PFS 2.7 months vs 1.4 months, HR 0.37 (0.25-0.54)OS 10.3 months vs 7.5 months, HR 0.79 (0.56-1.12), not significant (about 70% of placebo patients crossed over)

Trial details and side effects
Patients
previously treated IDH1-mutant cholangiocarcinoma (NCT02989857)
Most common side effects
fatigue, nausea, abdominal pain, diarrhoea, cough, decreased appetite, ascites, vomiting, anaemia, rash
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)
vorasidenib
FDA, 2024
grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, after surgery, age >=12 FDA approval 06/08/2024. Source
EU (EMA), 2025
predominantly non-enhancing grade 2 astrocytoma or oligodendroglioma, IDH1 R132 or IDH2 R172 mutation, after surgery only, age >=12 and >=40 kg EU marketing authorisation 17/09/2025. Source
Voranigovorasidenib page
glioma (grade 2) Approved 2024 Approved 2025

In the FDA approval summary

INDIGO vs placebo, 331 randomised (1:1)
PFS HR 0.39 (0.27-0.56)

Trial details and side effects
Patients
residual or recurrent grade 2 IDH-mutant glioma after surgery only (NCT04164901)
Most common side effects
fatigue, headache, COVID-19, musculoskeletal pain, diarrhoea, nausea, seizure
Later trial
Time to next intervention: not reached vs 17.8 months, HR 0.26 (0.15-0.43).
Notes
FDA approval summary (2024); published median PFS 27.7 vs 11.1 months. Side effects are those in 15% or more of patients.
Source
FDA approval summary

In the EU summary (EPAR)

INDIGO vs placebo, 331 randomised (1:1)
PFS about 28 months vs about 11 months, HR 0.39 (0.27-0.56)

Trial details and side effects
Patients
residual or recurrent grade 2 IDH-mutant glioma after surgery only (NCT04164901)
Most common side effects
fatigue, headache, COVID-19, musculoskeletal pain, diarrhoea, nausea, seizure
Later trial
Time to next intervention: not reached vs 17.8 months, HR 0.26 (0.15-0.43).
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)

Companion diagnostic tests

Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.

TestSampleForTumourSince
Abbott RealTime IDH2Abbott Molecular blood or bone marrow enasidenib AML 2017
Abbott RealTime IDH1Abbott Molecular blood or bone marrow ivosidenib, olutasidenib AML; MDS 2018
Oncomine Dx Target TestLife Technologies tissue ivosidenib cholangiocarcinoma 2021

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

25 of 43 drugs shown

DrugTypeActive trialsFurthest phaseLead sponsors
olutasidenib FDAIDH1 IDH1 inhibitor 10 Phase 4 Rigel Pharmaceuticals, Kissei Pharmaceutical
ivosidenib FDA EUIDH1 IDH1 inhibitor 27 Phase 3 Servier Affaires Médicales, Servier Bio-Innovation
enasidenib FDAIDH2 IDH2 inhibitor 13 Phase 3 Academic only
vorasidenib FDA EUIDH1/2 brain-penetrant IDH1/2 inhibitor 11 Phase 3 Servier, Servier (Tianjin) Pharmaceutical
venetoclaxBCL-2 BCL-2 inhibitor 14 Phase 3 Eli Lilly
safusidenibIDH1 IDH1 inhibitor 5 Phase 3 Nuvation Bio, Daiichi Sankyo
TQB3454 Not yet classified 3 Phase 3 Chia Tai Tianqing (Sino Biopharm)
HMPL-306IDH1/2 IDH1/2 inhibitor 2 Phase 3 HUTCHMED
bevacizumabVEGF-A anti-VEGF antibody 1 Phase 3 Academic only
vebreltinibMET MET TKI 1 Phase 2/3 Beijing Pearl Biotechnology
olaparibPARP PARP inhibitor 5 Phase 2 Academic only
abemaciclibCDK4/6 CDK4/6 inhibitor 3 Phase 2 Eli Lilly
niraparibPARP PARP inhibitor 3 Phase 1/2 Academic only
nivolumabPD-1 anti-PD-1 antibody 3 Phase 2 Academic only
pembrolizumabPD-1 anti-PD-1 antibody 3 Phase 2 Academic only
retifanlimabPD-1 anti-PD-1 antibody 3 Phase 1/2 Academic only
durvalumabPD-L1 anti-PD-L1 antibody 2 Phase 2 Eli Lilly
gilteritinibFLT3 FLT3 inhibitor 2 Phase 2 Academic only
avutometinibRAF/MEK RAF/MEK clamp 1 Phase 1/2 Academic only
AZD9574PARP1 PARP1-selective inhibitor (brain-penetrant) 1 Phase 1/2 AstraZeneca
ceralasertibATR ATR inhibitor 1 Phase 2 Academic only
datopotamab deruxtecanTROP2 TROP2 ADC 1 Phase 1/2 AstraZeneca
defactinibFAK FAK inhibitor 1 Phase 1/2 Academic only
FG001 Not yet classified 1 Phase 2 FluoGuide A/S
ipilimumabCTLA-4 anti-CTLA-4 antibody 1 Phase 2 Academic only

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

DueTrialPhaseDrugsSponsor
2026-11 Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated GliomaNCT02704858 · 49 patients Phase 1/2 Perillyl alcohol Neonc Technologies
2026-12 A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.NCT05987358 · 165 patients Phase 3 TQB3454 tablets, TQB3454 tablets matching placebo Chia Tai Tianqing (Sino Biopharm)
2026-12 Niraparib and Temozolomide in Patients GlioblastomaNCT06258018 · 86 patients Phase 1/2 niraparib Armando Santoro, MD
2027-01 Pembrolizumab, Olaparib, and Temozolomide for People With GliomaNCT05188508 · 57 patients Phase 2 pembrolizumab, olaparib Memorial Sloan Kettering Cancer Center
2027-02 A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following RadiotherapyNCT06413706 · 45 patients Phase 2 abemaciclib Eli Lilly
2027-02 Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic SyndromeNCT03383575 · 63 patients Phase 2 enasidenib M.D. Anderson Cancer Center
2027-03 Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)NCT06672146 · 93 patients Phase 2 enasidenib, venetoclax National Cancer Institute (NCI)
2027-03 Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)NCT06577441 · 54 patients Phase 2 enasidenib National Cancer Institute (NCI)
2027-03 AG-120 in People With IDH1 Mutant ChondrosarcomaNCT04278781 · 6 patients Phase 2 ivosidenib Memorial Sloan Kettering Cancer Center
2027-04 Olutasidenib DDI Study in Patients With IDH1 Mutation Positive MalignanciesNCT07486713 · 16 patients Phase 4 olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates Rigel Pharmaceuticals
2027-04 A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive ChemotherapyNCT03839771 · 968 patients Phase 3 ivosidenib, enasidenib Stichting Hemato-Oncologie voor Volwassenen Nederland
2027-04 IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic SyndromeNCT03503409 · 68 patients Phase 2 ivosidenib Groupe Francophone des Myelodysplasies
2027-04 Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)NCT01906385 · 55 patients Phase 1/2 Rhenium Liposome Treatment Cerenome
2027-05 Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDSNCT07607418 · 20 patients Phase 2 ivosidenib Ruijin Hospital
2027-06 Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway MutationsNCT07032727 · 68 patients Phase 2 olutasidenib, venetoclax, gilteritinib, Ruxolitinib M.D. Anderson Cancer Center
2027-06 All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant GliomaNCT05345002 · 55 patients Phase 2 retifanlimab, All-trans retinoic acid Stephen Bagley, MD, MSCE
2027-06 A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational BurdenNCT04145115 · 37 patients Phase 2 ipilimumab, nivolumab National Cancer Institute (NCI)
2027-07 Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain TumorsNCT03220646 · 64 patients Phase 2 abemaciclib Memorial Sloan Kettering Cancer Center
2027-08 A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.NCT06566742 · 15 patients Phase 2 olutasidenib M.D. Anderson Cancer Center
2027-09 VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent GliomaNCT07831369 · 52 patients Phase 2 Valproic Acid (VPA), Simvastatin Inova Health Care Services
2027-09 IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)NCT05401097 · 125 patients Phase 2 enasidenib, ivosidenib, venetoclax Alice Mims
2027-09 Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic MalignanciesNCT03471260 · 96 patients Phase 1/2 ivosidenib, venetoclax M.D. Anderson Cancer Center
2027-09 Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene MutationNCT03683433 · 50 patients Phase 2 enasidenib M.D. Anderson Cancer Center
2027-10 An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.NCT05907057 · 245 patients Phase 3 ivosidenib Servier Affaires Médicales

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

  1. Chia Tai Tianqing (Sino Biopharm) 3
  2. Nuvation Bio 3
  3. Eli Lilly 3
  4. HUTCHMED 2
  5. Servier Affaires Médicales 2
  6. GT Medical Technologies 1
  7. Rigel Pharmaceuticals 1
  8. Servier 1
  9. Servier Bio-Innovation 1
  10. Beijing Pearl Biotechnology 1
  11. Daiichi Sankyo 1
  12. FluoGuide A/S 1
  13. Kissei Pharmaceutical 1
  14. Philogen S.p.A. 1
  15. AstraZeneca 1

Trials

Matched automatically from registry text, so a few trials may only mention IDH1/2 mutation rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

Status
Match

149 of 224 trials shown

  1. Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

    Recruiting Phase 4 Rigel Pharmaceuticals Started 2026Primary completion 2027-04 NCT07486713

    olutasidenib FDACYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates

    Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

    AML (Acute Myeloid Leukemia), Glioma, Cholangiocarcinoma, Solid Tumor Malignancies

  2. GammaTile and Stupp in Newly Diagnosed GBM

    Active, not recruiting Phase 4 GT Medical Technologies Started 2022Primary completion 2027-12 NCT05342883

    …ation of newly diagnosed GBM using IDH mutation testing (such as immunohistochemistry for IDH1 R132H) must be performed as part of SOC.

    Glioblastoma

  3. Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

    Not yet recruiting Phase 3 Nuvation Bio Starts 2027Primary completion 2029-05 NCT07712757

    safusidenib

    Histologically confirmed Grade 2, IDH1-mutant oligodendroglioma or astrocytoma according to World Health Organization Central Nervous S…

    Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted

  4. Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer

    Recruiting Phase 3 Alliance for Clinical Trials in Oncology Started 2026Primary completion 2033-05 NCT07215910

    temozolomidevorasidenib FDA EU

    STEP 0: Histologic diagnosis of astrocytoma, IDH-mutant (central nervous system \[CNS\] WHO grade 3)

    Astrocytoma, IDH-Mutant, Grade 3

  5. Vorasidenib Maintenance for IDH Mutant Astrocytoma

    Recruiting Phase 3 European Organisation for Research and Treatment of Cancer - EORTC Started 2026Primary completion 2035-04 NCT06809322

    vorasidenib FDA EU

    Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment

    IDH-mutant Grade 2 or 3 Astrocytoma

  6. Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

    Recruiting Phase 3 Stichting Hemato-Oncologie voor Volwassenen Nederland Started 2025Primary completion 2028-12 NCT07075016

    venetoclax

    Patient with newly diagnosed IDH1-mutated AML, or IDH1-mutated MDS/AML according to the 2022 International Consensus Classification…

    Acute Myeloid Leukemia

  7. Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

    Recruiting Phase 3 Servier Bio-Innovation Started 2024Primary completion 2028-02 NCT06127407

    ivosidenib FDA EU

    Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available that …

    Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

  8. A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia

    Recruiting Phase 3 HUTCHMED Started 2024Primary completion 2028-12 NCT06387069

    HMPL-306Salvage Chemotherapy Regimen

    Cohort 1: Patients with R/R primary AML harboring IDH1-R132 site mutation \[WHO 2022 Classification Criteria for Myeloid Neoplasms and Acute Leukemia…

    Acute Myeloid Leukemia

  9. Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

    Active, not recruiting Phase 3 Servier Started 2024Primary completion 2026-05 NCT06780930

    vorasidenib FDA EU

    Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) g…

    Residual or Recurrent Grade 2 IDH Mutant Glioma

  10. Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

    Recruiting Phase 3 Institut de Recherches Internationales Servier Started 2024Primary completion 2027-11 NCT06465953

    ivosidenib FDA EUazacitidine

    Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):

    Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), Myelodysplastic Syndromes (MDS)

  11. An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

    Active, not recruiting Phase 3 Servier Affaires Médicales Started 2023Primary completion 2027-12 NCT05876754

    ivosidenib FDA EU

    Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease

    Cholangiocarcinoma

  12. SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

    Recruiting Phase 3 Nuvation Bio Started 2023Primary completion 2028-12 NCT05303519

    safusidenib

    …stologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.

    Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3

  13. A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.

    Active, not recruiting Phase 3 Chia Tai Tianqing (Sino Biopharm) Started 2023Primary completion 2026-12 NCT05987358

    TQB3454 tabletsTQB3454 tablets matching placebo

    …ablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.

    Biliary Carcinoma

  14. An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.

    Recruiting Phase 3 Servier Affaires Médicales Started 2023Primary completion 2027-10 NCT05907057

    ivosidenib FDA EUazacitidine

    Have a documented IDH1 R132 gene-mutated disease

    Acute Myeloid Leukemia (AML)

  15. A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

    Recruiting Phase 3 Hospices Civils de Lyon Started 2021Primary completion 2030-12 NCT04702581

    PCV chemotherapyRadiotherapy and PCV chemotherapy

    Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to local diagnosis

    Oligodendroglioma, Low-grade Oligodendroglioma, 1p19q Codeletion

  16. A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).

    Recruiting Phase 3 University Hospital Heidelberg Started 2021Primary completion 2033-03 NCT05331521

    temozolomidevincristine

    Tumor carries an isocitrate dehydrogenase (IDH) mutation (determined by immunohistochemistry (IHC) and/or deoxyribonucleic acid (DNA) sequencing).

    Oligodendroglioma

  17. Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

    Active, not recruiting Phase 3 Institut de Recherches Internationales Servier Started 2020Primary completion 2022-09 NCT04164901

    vorasidenib FDA EUMatching Placebo

    Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) g…

    Grade 2 Glioma, Residual Glioma, Recurrent Glioma

  18. A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

    Active, not recruiting Phase 3 Stichting Hemato-Oncologie voor Volwassenen Nederland Started 2019Primary completion 2027-04 NCT03839771

    ivosidenib FDA EUenasidenib FDA

    Newly diagnosed AML or MDS-EB2 defined according to WHO criteria, with a documented IDH1 or IDH2 gene mutation (as determined by the clinical trial assay) at a specific site (IDH1 R132, IDH2 R140, IDH…

    Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2

  19. A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).

    Active, not recruiting Phase 2/3 Beijing Pearl Biotechnology Started 2018Primary completion 2023-04 NCT06105619

    vebreltinibtemozolomidecisplatinetoposide

    A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).

    Glioblastoma

  20. Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

    Active, not recruiting Phase 3 Institut de Recherches Internationales Servier Started 2017Primary completion 2021-03 NCT03173248

    ivosidenib FDA EUazacitidine

    Have an isocitrate dehydrogenase 1 (IDH1) mutation.

    Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute

  21. Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

    Active, not recruiting Phase 3 Alliance for Clinical Trials in Oncology Started 2009Primary completion 2029-10 NCT00887146

    temozolomideprocarbazineCCNUvincristine

    Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review

    Brain and Central Nervous System Tumors

  22. Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study

    Not yet recruiting Phase 2 University of Zurich Starts 2027Primary completion 2029-03 NCT07832123

    safusidenib

    Newly diagnosed and histologically confirmed IDH1-mutant WHO grade 3 glioma, without or with residual disease: astrocytoma IDH1-mutant, or oligode…

    Glioma : Oligodendroglioma or Astrocytoma

  23. Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

    Recruiting Phase 2 Nuvation Bio Starts 2027Primary completion 2030-09 NCT07703436

    safusidenib

    Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 20…

    Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma

  24. IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade Astrocytomas

    Not yet recruiting Phase 2 German Cancer Research Center Starts 2027Primary completion 2034-02 NCT07888647

    IDH1-vacIS-vactemozolomideImiquimod 5 % Cream

    …ients present with newly diagnosed histologically confirmed WHO grade 3 to 4 astrocytoma, IDH1R132H-positive (with or without measurable residual tumor after tumor resection or biopsy)

    Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4

  25. A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

    Recruiting Phase 2 Kissei Pharmaceutical Started 2026Primary completion 2030-09 NCT07604064

    olutasidenib FDA

    Patients with IDH1 gene mutation confirmed by central confirmation after relapse or refractoriness

    Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia

  26. Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy

    Recruiting Phase 2 Justin Watts, MD Started 2026Primary completion 2029-03 NCT06782542

    olutasidenib FDAvenetoclaxazacitidine

    Newly diagnosed AML Isocitrate dehydrogenase 1 (IDH1) R132 mutated disease as assessed locally.

    Acute Myeloid Leukemia, IDH1 Mutation

  27. A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma

    Not yet recruiting Phase 2 Philogen S.p.A. Started 2026Primary completion 2029-01 NCT07120984

    L19TNFtemozolomideL19TNF and CCNUL19TNF monotherapyL19TNF and CCNU in recurrent astrocytomaL19TNF monothery in recurrent oligodendroglioma

    IDH-mutant glioma (according to WHO 2021 classification) at first recurrence or progression after al…

    Glioma

  28. VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma

    Recruiting Phase 2 Inova Health Care Services Started 2026Primary completion 2027-09 NCT07831369

    Valproic Acid (VPA)irinotecanSimvastatin

    Diagnosis of glioblastoma or IDH-mutated glioma by WHO 2021 classification

    Glioblastoma, Astrocytoma, IDH-Mutant, Grade 4

  29. Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas

    Recruiting Phase 1/2 Mayo Clinic Started 2026Primary completion 2030-10 NCT07468136

    Eflornithineretifanlimab

    Grade 3 or 4 IDH1/2 mutant astrocytoma or

    Anaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4, Diffuse Astrocytoma

  30. Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Patients Diagnosed With a Glioma

    Not yet recruiting Phase 2 Barbara Ann Karmanos Cancer Institute Started 2026Primary completion 2031-06 NCT07735819

    Minocycline 200mg/day

    MRI diagnosis of a brain tumor, previously verified to be a low-grade (WHO grade 2, IDH (isocitrate dehydrogenase) mutant glioma, based on histopathology from biopsy or resection.

    Low Grade Glioma, Glioblastoma

  31. FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma

    Not yet recruiting Phase 2 FluoGuide A/S Started 2026Primary completion 2028-07 NCT07609472

    FG001

    Astrocytoma, IDH-mutant (CNS WHO Grade 3 or 4)

    High-Grade Glioma (WHO III-IV)

  32. Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients

    Recruiting Phase 2 PETHEMA Foundation Started 2026Primary completion 2029-04 NCT07507760

    decitabineivosidenib FDA EUHydroxyureacytarabine

    IDH1 R132 mutations (centrally assessed by PCR and NGS).

    Acute Myeloid Leukemia With Gene Mutations

  33. Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.

    Not yet recruiting Phase 2 French Innovative Leukemia Organisation Started 2026Primary completion 2030-09 NCT07463768

    ivosidenib FDA EUazacitidine

    Presence of IDH1 R132 mutation at AML diagnosis

    Acute Myeloid Leukemia

  34. Clinical Trial Evaluating the Efficacy and Safety of TQB3454 Tablets in Participants With Advanced Solid Tumors

    Not yet recruiting Phase 2 Chia Tai Tianqing (Sino Biopharm) Started 2026Primary completion 2028-12 NCT07738679

    TQB3454 tablets

    …ens obtained through surgery or biopsy, and cohort 1 and cohort 2 were confirmed to carry IDH1 R132 gene mutation by molecular testing

    Advanced Solid Tumors

  35. GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma

    Recruiting Phase 2 Mayo Clinic Started 2026Primary completion 2029-09 NCT07301268

    Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102pembrolizumab

    and IDH mutated WHO grade 4 astrocytoma

    Glioblastoma, IDH-Wildtype, Progressive Astrocytoma, IDH-Mutant, Grade 4, Progressive Glioblastoma, Progressive Gliosarcoma

  36. Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

    Recruiting Phase 2 Timothy Pardee Started 2026Primary completion 2028-06 NCT07471841

    olutasidenib FDAazacitidine

    Acute Myeloid Leukemia with a documented IDH1 mutation.

    IDH1 Mutation, Relapsed / Refractory AML

  37. Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations

    Not yet recruiting Phase 2 Shen yang Started 2026Primary completion 2028-05 NCT07664839

    azacitidinecytarabinedaunorubicin

    …is accompanied by NPM1 mutations (A, B, D types and rare types are all acceptable) and/or IDH1/IDH2 mutations;

    Acute Myeloid Leukemia, NPM1 Mutation, IDH1 Mutation, IDH2 Mutation

  38. Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow

    Recruiting Phase 2 Tata Memorial Centre Started 2026Primary completion 2028-07 NCT06492486

    Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) need radiotherapy (stratum B).

    Diffuse Glioma, Glioblastoma, Adaptive Radiotherapy, Artificial Intelligence

  39. Ivosidenib as Post-HSCT Maintenance for AML

    Recruiting Phase 2 Massachusetts General Hospital Started 2026Primary completion 2028-01 NCT06707493

    ivosidenib FDA EU

    IDH1 mutations could have been detected by any mutational technique at any prior point including at diag…

    IDH1 Mutation, Acute Myeloid Leukemia (AML), Hematopoietic Stem Cell Transplant (HSCT)

  40. Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy)

    Not yet recruiting Phase 2 National Cancer Institute (NCI) Started 2026Primary completion 2030-04 NCT07153497

    decitabineolutasidenib FDAvenetoclax

    …n the MYELOMATCH Master Screening and Reassessment Protocol (MSRP), determined to have an IDH1-R132 mutation and assigned to this trial via MATCHBox

    Acute Myeloid Leukemia, Myelodysplastic Syndrome

  41. A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2028-01 NCT07392242

    ivosidenib FDA EUazacitidinevenetoclax

    Participant has IDH1-R132 mutation present prior to initiating Ivo/Aza/Ven confirmed by CLIA approved local testing…

    Acute Myeloid Leukemia

  42. Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS

    Recruiting Phase 2 Ruijin Hospital Started 2026Primary completion 2027-05 NCT07607418

    ivosidenib FDA EU

    Molecularly confirmed diagnosis of IDH1-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

    AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)

  43. Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia

    Not yet recruiting Phase 1/2 Shanghai Jiao Tong University School of Medicine Started 2026Primary completion 2027-10 NCT07486726

    Aclarubicinvenetoclaxazacitidine

    … with relapsed/refractory AML after intensive chemotherapy (Exclude patients with FLT3 or IDH1/2 mutations who have not previously received targeted therapy).

    Acute Myeloid Leukemia (AML), Relapse Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia (AML)

  44. Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2025Primary completion 2027-03 NCT06672146

    decitabineenasidenib FDAvenetoclax

    …x Compared With ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy

    Acute Myeloid Leukemia

  45. Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2025Primary completion 2027-03 NCT06577441

    decitabineenasidenib FDA

    REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel.

    Myelodysplastic Syndrome

  46. Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML

    Recruiting Phase 1/2 Institute of Hematology & Blood Diseases Hospital Started 2025Primary completion 2026-10 NCT06611839

    ivosidenib FDA EUvenetoclaxazacitidine

    Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML

    AML, IDH1 Mutation, Treatment

  47. Study of How Safe and Effective Tarlatamab is in Brain Cancers

    Recruiting Phase 2 University Health Network, Toronto Started 2025Primary completion 2028-03 NCT06776250

    Tarlatamab

    …tic or oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.

    Astrocytic Tumor, Oligodendroglial Tumor

  48. a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

    Recruiting Phase 2 The First Affiliated Hospital of Soochow University Started 2025Primary completion 2026-04 NCT07007949

    ivosidenib FDA EUvenetoclaxazacitidine

    a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

    Acute Myeloid Leukemia, IDH1 Gene Mutation, Ivosidenib

  49. Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation

    Recruiting Phase 2 Technische Universität Dresden Started 2025Primary completion 2029-10 NCT06717958

    ivosidenib FDA EU

    AML or MDS with IDH1 mutation

    AML, MDS

  50. Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

    Active, not recruiting Phase 1/2 Institut de Recherches Internationales Servier Started 2025Primary completion 2027-11 NCT06478212

    vorasidenib FDA EUtemozolomide

    Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

    IDH1-mutant Glioma, IDH2-mutant Glioma

  51. Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

    Recruiting Phase 2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Started 2025Primary completion 2030-12 NCT07260175

    ivosidenib FDA EU

    …se II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

    Cholangiocarcinoma, IDH Mutation

  52. Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent

    Recruiting Phase 2 University of California, Davis Started 2025Primary completion 2027-12 NCT07304011

    azacitidineolutasidenib FDA

    Documented IDH1-R132 mutations (≥ 0.01%) detected in the bone marrow or blood.

    Acute Myeloid Leukemia

  53. Tuvusertib in Astrocytoma With ATRX Mutation

    Recruiting Phase 2 Grupo Español de Investigación en Neurooncología Started 2025Primary completion 2028-09 NCT07417761

    Tuvusertib

    Diagnosis of Grade 2-4 astrocytoma, IDH-mutated according to the 2021 WHO classification.

    Astrocytoma

  54. Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2025Primary completion 2027-06 NCT07032727

    olutasidenib FDAcladribinevenetoclaxgilteritinibRuxolitinibcytarabine

    Participants must have a documented IDH1 mutation.

    Targeted Therapy, IDH1-Mutated Malignancies, Mutations

  55. A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2024Primary completion 2027-08 NCT06566742

    olutasidenib FDA

    A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Ch…

    Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Clonal Cytopenia of Undetermined Significance

  56. A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

    Active, not recruiting Phase 2 Eli Lilly Started 2024Primary completion 2027-02 NCT06413706

    abemaciclibtemozolomide

    IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletio…

    Glioma

  57. 5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours

    Recruiting Phase 1/2 Institute of Cancer Research, United Kingdom Started 2024Primary completion 2029-09 NCT06630260

    avutometinibdefactinibtemozolomide

    Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2/3 are not included)

    Glioblastoma Multiforme (GBM), Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Malignant Primary Gliomas

  58. Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2024Primary completion 2027-12 NCT06176989

    enasidenib FDA

    …lly advanced or metastatic SNUC, ONB, LCNEC, SNAC, and CS with documented somatic (tumor) IDH2 mutations R140 or R172.

    Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma, Locally Advanced Sinonasal Adenocarcinoma

  59. Niraparib and Temozolomide in Patients Glioblastoma

    Not yet recruiting Phase 1/2 Armando Santoro, MD Started 2024Primary completion 2026-12 NCT06258018

    temozolomideniraparib

    Patients with diagnosis of recurrent/progressive IDH mutant gliomas (WHO 2021, grade 2-4).

    Status may be outdated, last updated 2024-08-30Glioma, Malignant

  60. A Study of Enasidenib in People With T-Cell Lymphoma

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2024Primary completion 2027-12 NCT06756308

    enasidenib FDArituximab

    Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2 mutation (by MSK ddPCR).

    T-cell Lymphoma

  61. A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2024Primary completion 2027-12 NCT06668584

    olutasidenib FDA

    Evdence of an IDH1 mutation presence by next generation sequencing panel at original diagnosis.

    Myeloid Malignancies

  62. An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.

    Recruiting Phase 2 Peking Union Medical College Hospital Started 2024Primary completion 2026-10 NCT07282262

    ivosidenib FDA EUlenvatinibPD-1/PD-L1 inhibitor

    Genetic Mutation: Presence of an IDH1 mutation confirmed by genetic testing.

    Biliary Tract Cancer

  63. 000860: A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations

    Recruiting Phase 1/2 National Cancer Institute (NCI) Started 2023Primary completion 2028-08 NCT05588141

    Zotiraciclib

    …udy of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations

    Brain Tumor, Cancer

  64. A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

    Recruiting Phase 1/2 Debiopharm International Started 2023Primary completion 2028-09 NCT05765812

    Debio 0123temozolomide

    Astrocytoma, IDH-mutant, Grade 3

    Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III

  65. Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

    Active, not recruiting Phase 2 Children's Oncology Group Started 2023Primary completion 2025-09 NCT04203316

    enasidenib FDA

    Patient must have AML with an IDH2 mutation identified from a peripheral blood or bone marrow sample at the time of diagnosis and/or …

    Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

  66. All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma

    Recruiting Phase 2 Stephen Bagley, MD, MSCE Started 2022Primary completion 2027-06 NCT05345002

    retifanlimabAll-trans retinoic acid

    All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma

    Glioma, IDH Mutation, Astrocytoma, Oligodendroglioma

  67. UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly

    Active, not recruiting Phase 2 Sunnybrook Health Sciences Centre Started 2022Primary completion 2027-12 NCT05565521

    …onfirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma, IDH-mutant

    Glioblastoma Multiforme, Adult, Glioblastoma, IDH-mutant

  68. Pembrolizumab, Olaparib, and Temozolomide for People With Glioma

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2022Primary completion 2027-01 NCT05188508

    pembrolizumabolaparibtemozolomide

    Histologically confirmed grade II or III IDH-mutated glioma (absence of known CDKN2A/B deletion) that has recurred after first line therapy (c…

    Glioma

  69. IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

    Recruiting Phase 2 Alice Mims Started 2022Primary completion 2027-09 NCT05401097

    azacitidineenasidenib FDAivosidenib FDA EUvenetoclax

    Patients with newly diagnosed IDH1 or IDH2 mutated AML

    Acute Myeloid Leukemia

  70. Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 AstraZeneca Started 2022Primary completion 2028-02 NCT05417594

    AZD9574temozolomide[11C]AZ1419 3391trastuzumab deruxtecandatopotamab deruxtecan

    Must be suitable for treatment with TMZ and have IDH1/2-mutant glioma.

    Advanced Solid Malignancies

  71. Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2021Primary completion 2027-11 NCT04774393

    decitabineenasidenib FDAivosidenib FDA EUvenetoclax

    Subjects must have documented IDH1 or IDH2 gene mutation

    Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

  72. A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

    Active, not recruiting Phase 2 Daiichi Sankyo Started 2020Primary completion 2023-03 NCT04458272

    safusidenib

    Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.

    WHO Grade II Glioma

  73. AG-120 in People With IDH1 Mutant Chondrosarcoma

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2020Primary completion 2027-03 NCT04278781

    ivosidenib FDA EU

    Have a documented IDH1 gene mutation (from a fresh tumor biopsy or from archived tumor tissue) confirmed by a CLIA approved la…

    Chondrosarcoma, Chondrosarcoma, Grade 2, Chondrosarcoma, Grade 3, IDH1 Gene Mutation

  74. A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2027-06 NCT04145115

    ipilimumabnivolumab

    Astrocytoma, IDH-mutant CNS WHO grade 4

    Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma, Glioblastoma, IDH-Wildtype, Secondary Glioblastoma

  75. Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2025-03 NCT03878095

    ceralasertibolaparib

    Patients must have biopsy-confirmed evidence of an IDH1 or IDH2 mutation, confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, associat…

    Malignant Solid Neoplasm, Refractory Cholangiocarcinoma, Refractory Malignant Solid Neoplasm

  76. Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2025-03 NCT04195555

    ivosidenib FDA EU

    … in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)

    Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis

  77. Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2024-01 NCT03953898

    olaparib

    Patients must have a documented IDH1 or IDH2 mutation within 30 days of inclusion based on mutational testing.

    Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy, Recurrent Acute Myeloid Leukemia

  78. CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2020Primary completion 2028-06 NCT04493164

    ivosidenib FDA EUdaunorubicincytarabineCPX-351

    IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e.

    Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia

  79. Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2019Primary completion 2024-11 NCT03718767

    nivolumab

    Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype

    Glioma, Glioblastoma, High Grade Glioma, Low Grade Glioma

  80. IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

    Active, not recruiting Phase 2 Groupe Francophone des Myelodysplasies Started 2019Primary completion 2027-04 NCT03503409

    ivosidenib FDA EU

    Presence of IDH1 mutation in either blood or marrow prior to start of therapy;

    Myelodysplastic Syndromes, Acute Myeloid Leukemia

  81. Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

    Active, not recruiting Phase 2 University Health Network, Toronto Started 2019Primary completion 2026-09 NCT03991832

    olaparibdurvalumab

    …ic and oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.

    Glioma, Cholangiocarcinoma, Solid Tumor, IDH Mutation

  82. Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2019Primary completion 2025-04 NCT03212274

    olaparib

    …, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteins

    Advanced Malignant Solid Neoplasm, Glioblastoma, Recurrent Cholangiocarcinoma, Recurrent Glioma

  83. IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

    Active, not recruiting Phase 2 Groupe Francophone des Myelodysplasies Started 2019Primary completion 2023-02 NCT03744390

    enasidenib FDA

    Presence of IDH2 mutation in either blood or marrow prior to start of therapy

    Myelodysplastic Syndromes, Leukemia Acute Myeloid

  84. Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2018Primary completion 2027-09 NCT03471260

    azacitidineivosidenib FDA EUvenetoclax

    IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e.

    Acute Myeloid Leukemia, Hematopoietic and Lymphoid System Neoplasm, Myelodysplastic Syndrome, Myeloproliferative Neoplasm

  85. Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations

    Active, not recruiting Phase 2 Children's Oncology Group Started 2018Primary completion 2023-03 NCT03581292

    temozolomideveliparib

    Stratum 2 (IDH mutant): Patients must be \>= 3 years of age and =\< 25 years of age at the time of enrollment

    Anaplastic Astrocytoma, Glioblastoma, Malignant Glioma

  86. Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma

    Active, not recruiting Phase 2 NRG Oncology Started 2018Primary completion 2026-07 NCT03180502

    temozolomide

    Grade II and III gliomas IDH mutant gliomas including

    Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma, Diffuse Astrocytoma

  87. Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2018Primary completion 2027-02 NCT03383575

    azacitidineenasidenib FDA

    Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result

    Acute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation

  88. Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2018Primary completion 2027-09 NCT03683433

    azacitidineenasidenib FDA

    Subjects must have documented IDH2 gene mutation

    Acute Bilineal Leukemia, Acute Biphenotypic Leukemia, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation

  89. Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma

    Active, not recruiting Phase 1/2 Neonc Technologies Started 2017Primary completion 2026-11 NCT02704858

    Perillyl alcohol

    Patients must have a confirmed IDH1 mutation by reverse transcription polymerase chain reaction (rtPCR) or immunohistochemistry (unles…

    Glioblastoma Multiforme

  90. A Study of Abemaciclib in Recurrent Glioblastoma

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2017Primary completion 2024-06 NCT02981940

    abemaciclib

    or astrocytoma, IDH-mutant, WHO grade 4 (1 unstained slide or 1 H\&E slide must be submitted to and reviewed by a pa…

    Glioblastoma

  91. A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL)

    Not yet recruiting Phase 1 Heidelberg University Starts 2027Primary completion 2032-12 NCT07877415

    IDH1R132H-vacvorasidenib FDA EUAldara - Imiquimod 5%

    …equivocal first, second or third recurrence of a histologically and molecularly confirmed IDH1R132H-mutated astrocytoma WHO grade 2, 3 and 4 recurrent and/or progressive after radiotherapy …

    Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4

  92. Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma

    Not yet recruiting Phase 1 National Cancer Institute (NCI) Started 2026Primary completion 2027-02 NCT07422363

    cemiplimab

    Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots

    Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma, Recurrent WHO Grade 4 Glioma

  93. Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation

    Recruiting Phase 1 Virginia Commonwealth University Started 2026Primary completion 2028-10 NCT07130695

    olutasidenib FDA

    …ologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML).

    Acute Myeloid Leukemia

  94. Chronic CED of TPT for Recurrent Malignant Glioma

    Recruiting Phase 1 Jeffrey N. Bruce Started 2026Primary completion 2028-01 NCT06666712

    topotecan

    Patients with a history of WHO grade 2 recurrent glioma, IDH-Mutant, who now demonstrate high-grade features of IDH-mutant WHO grade 3-4 will also be include…

    Brain Tumor, Recurrent, Malignant Glioma (WHO Grade III or IV), IDH1/IDH2 Mutation

  95. VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

    Not yet recruiting Phase 1 Megan Mantica Started 2026Primary completion 2030-06 NCT07629089

    vorasidenib FDA EULomustine

    Must have recurrent IDH-mutant oligodendroglioma or astrocytoma grade 2-4 harboring IDH1 and/or IDH2 mutation per WHO 20…

    Recurrent Glioma, IDH-mutant Gliomas

  96. Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma

    Enrolling by invitation Phase 1 Andrew P. Groves Started 2025Primary completion 2028-03 NCT06896110

    nivolumabazacitidine

    …t with at least radiotherapy (and temozolomide in the case of glioblastoma or astrocytoma IDH-mutant (grade 4))

    Glioblastoma (GBM), Diffuse Midline Glioma (DMG), Astrocytoma, IDH-Mutant, Grade 4, Diffuse Hemispheric Glioma, H3 G34-Mutant

  97. ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

    Recruiting Phase 1 Katy Peters, MD, PhD Started 2025Primary completion 2027-08 NCT05609994

    vorasidenib FDA EU

    IDH1R132H expression in primary tumor

    Low Grade Glioma of Brain

  98. Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma

    Active, not recruiting Phase 1 Children's Oncology Group Started 2025Primary completion 2028-03 NCT06894979

    ATM Kinase Inhibitor AZD1390

    IDH-mutant

    Childhood Astrocytoma, Childhood Diffuse Intrinsic Pontine Glioma, Childhood Diffuse Midline Glioma, Childhood Glioblastoma

  99. Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2025Primary completion 2027-06 NCT06860594

    Triapine

    Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)

    Astrocytoma, IDH-Mutant, Grade 2, Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant, Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant, Recurrent Astrocytoma, IDH-Mutant

  100. A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma

    Recruiting Phase 1 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2025Primary completion 2028-01 NCT07306299

    Glioma-related multi-target mRNA vaccines

    …more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII.

    Glioma, High Grade

  101. Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations

    Recruiting Phase 1 HUTCHMED Started 2025Primary completion 2026-12 NCT07025018

    HMPL-306

    Safety Lead-In Phase: Patients with gliomas of a documented IDH1 and/or IDH2 mutation.

    Gliomas Harboring IDH1 and/or IDH2 Mutations

  102. Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma

    Recruiting Phase 1 City of Hope Medical Center Started 2025Primary completion 2030-10 NCT06815029

    Chimeric Antigen Receptor T-Cell Therapy

    Participant has a prior histologically-confirmed diagnosis of a grade 3 or 4 IDH-mutant astrocytoma or glioblastoma, or has a prior histologically-confirmed diagnosis of a grade…

    Recurrent Astrocytoma, IDH-Mutant, Grade 3, Recurrent Astrocytoma, IDH-Mutant, Grade 4, Recurrent Glioblastoma

  103. 5G-EMERALD: Amivantamab in Malignant Brain Tumours

    Active, not recruiting Phase 1 Institute of Cancer Research, United Kingdom Started 2024Primary completion 2027-07 NCT06632236

    amivantamab

    Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2/3 are not included)

    Malignant Primary Gliomas, Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Glioblastoma Multiforme (GBM)

  104. ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

    Recruiting Phase 1 University of Florida Started 2024Primary completion 2027-12 NCT06254326

    TTRNA-DC vaccines with GM-CSFAutologous Hematopoietic Stem cells (HSCs)TTRNA-xALTTd vaccine

    Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted Oligodendroglioma WHO grade 2 or WHO grade 3, more than 12 weeks from c…

    Recurrent Oligodendroglioma, Progressive Oligodendroglioma

  105. Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation

    Recruiting Phase 1 University of Chicago Started 2024Primary completion 2029-05 NCT06291987

    ivosidenib FDA EURuxolitinib

    Advanced-Phase IDH1-mutated Ph-negative MPNs (both untreated and relapsed/refractory) including any of the following:

    Myeloproliferative Neoplasms

  106. ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma

    Recruiting Phase 1 Mayo Clinic Started 2024Primary completion 2028-05 NCT05917145

    WSD0628

    Grade 3 or 4 IDH1/2 mutant astrocytoma (2021 WHO classification)

    Glioblastoma

  107. First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor

    Recruiting Phase 1 Jubilant Therapeutics Started 2024Primary completion 2028-03 NCT07755397

    JBI-778

    IDH-mutated WHO Grade 3/4 recurrent glioma

    NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic, Adenoid Cystic Carcinoma of the Head and Neck

  108. Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma

    Active, not recruiting Phase 1 Washington University School of Medicine Started 2023Primary completion 2026-04 NCT05743595

    Personalized Neoantigen DNA vaccineretifanlimab

    Patients with secondary glioblastoma, in particular those who are IDH1 or IDH2 mutant, will not be excluded.

    Unmethylated Glioblastoma

  109. A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

    Active, not recruiting Phase 1 Nuvectis Pharma Started 2023Primary completion 2027-03 NCT05873686

    NXP900

    …gene mutation or TYMS, YAP1, YES1, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations.

    Advanced Solid Tumor, NSCLC (Non-small Cell Lung Cancer), Renal Cancer, Mesothelioma

  110. A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

    Active, not recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2027-04 NCT05756777

    gilteritinibivosidenib FDA EUenasidenib FDA

    Patient has relapsed or refractory AML with dually mutant IDH2/FLT3, IDH1/FLT3 (ITD or TKD) , or other FLT3 mutation sensitive to gilteritinib.

    Acute Myeloid Leukemia (AML)

  111. A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia

    Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2027-12 NCT06017258

    CD371-specific/YSNVz/I-18 CAR T cells

    …y AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib

    Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse

  112. Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

    Active, not recruiting Phase 1 Institut de Recherches Internationales Servier Started 2023Primary completion 2026-02 NCT05484622

    vorasidenib FDA EUpembrolizumab

    Documented IDH1-R132H gene mutation

    Astrocytoma, Oligodendroglioma

  113. Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

    Active, not recruiting Phase 1 AbbVie Started 2022Primary completion 2027-11 NCT05599984

    ABBV-706cisplatinbudigalimabcarboplatin

    oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3

    Advanced Solid Tumors

  114. Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma

    Active, not recruiting Phase 1 Washington University School of Medicine Started 2020Primary completion 2022-05 NCT04015700

    Personalized neoantigen DNA vaccine supplied by Geneos TherapeuticsPlasmid encoded IL-12

    Patients with secondary glioblastoma, in particular those who are IDH1 or IDH2 mutant, will not be excluded.

    Glioblastoma

  115. Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 1 Eli Lilly Started 2020Primary completion 2023-07 NCT04603001

    LY3410738venetoclaxazacitidine

    Advanced IDH mutant hematologic malignancy including:

    Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasms (MPNs)

  116. Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 1 Eli Lilly Started 2020Primary completion 2023-07 NCT04521686

    LY3410738gemcitabinecisplatindurvalumab

    Evidence of IDH1 R132 mutation (any solid tumor) or circulating tumor DNA IDH2 R140 or IDH2 R172 mutation (chol…

    Cholangiocarcinoma, Chondrosarcoma, Glioma, Any Solid Tumor

  117. ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas

    Recruiting Phase 1 Massachusetts General Hospital Started 2019Primary completion 2027-01 NCT03922555

    decitabine

    …s must have histologically or cytologically confirmed glioma, with documented IDH1 and/or IDH2 gene-mutation.

    Neurological Cancer

  118. A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

    Recruiting Phase 1 Chia Tai Tianqing (Sino Biopharm) Started 2019Primary completion 2025-12 NCT06550713

    azacitidine

    Clearly indicating the presence of IDH2 gene mutation;

    Status may be outdated, last updated 2024-08-13Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

  119. Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2019Primary completion 2024-12 NCT03528642

    Telaglenastat Hydrochloridetemozolomide

    Patients must have histopathologic or molecular confirmation of either IDH-mutant DA or IDH-mutant AA.

    Astrocytoma, IDH-Mutant, Grade 2, Astrocytoma, IDH-Mutant, Grade 3

  120. BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

    Active, not recruiting Phase 1 University of California, San Francisco Started 2019Primary completion 2026-06 NCT03749187

    pamiparibtemozolomide

    …ave histologically confirmed World Health Organization (WHO) grade III-IV newly diagnosed IDH1/2-mutant glioma.

    Glioblastoma, IDH1 Gene Mutation, IDH2 Gene Mutation, Low Grade Glioma

  121. A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer

    Active, not recruiting Phase 1 Fujifilm Pharmaceuticals U Started 2018Primary completion 2026-10 NCT03440450

    gemcitabine

    …erapies directed against fibroblast growth factor (FGFR) and/or isocitrate dehydrogenase (IDH) mutations for tumors appropriately treated with such therapies

    Advanced Solid Tumors, Biliary Tract Cancer

  122. A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

    Active, not recruiting Phase 1 Novartis Started 2015Primary completion 2016-12 NCT02381886

    IDH305

    Documented IDH1R132-mutant tumors

    Advanced Malignancies That Harbor IDHR132 Mutations

  123. Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

    Active, not recruiting Phase 1 Institut de Recherches Internationales Servier Started 2015Primary completion 2018-12 NCT02632708

    ivosidenib FDA EUenasidenib FDAcytarabinedaunorubicinidarubicinmitoxantroneetoposide

    …e promyelocytic leukemia (APL) \[AML with t(15;17)\], with locally documented IDH1 and/or IDH2 gene mutation scheduled for induction therapy followed by consolidation therapy.

    Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), AML Arising From Antecedent Hematologic Disorder (AHD)

  124. Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

    Recruiting Phase 1 Institut de Recherches Internationales Servier Started 2014Primary completion 2026-12 NCT02074839

    ivosidenib FDA EU

    Subjects must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation.

    Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes

  125. Window of Opportunity Study of DSP-0390 in Gliomas

    Recruiting Early Phase 1 Washington University School of Medicine Started 2025Primary completion 2027-04 NCT06636162

    DSP-0390

    …lioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements:

    Glioma, Malignant, IDH Mutation

  126. Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease

    Recruiting Early Phase 1 Mayo Clinic Started 2025Primary completion 2028-09 NCT07025226

    DasatinibFisetinQuercetintemozolomideTopoisomerase-1 Inhibitor LMP744Single Agent Therapy

    Must have IDH-mutant OR MGMT-methylated glioma

    Glioma

  127. Niraparib In Recurrent IDH 1/2 Gliomas

    Active, not recruiting Early Phase 1 Massachusetts General Hospital Started 2023Primary completion 2026-07 NCT05406700

    niraparib

    …s must have histologically or cytologically confirmed glioma, with documented IDH1 and/or IDH2 gene-mutation at time of initial diagnosis

    Low-grade Glioma, IDH2 Gene Mutation, Recurrent Glioma, IDH1 Mutation

  128. Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

    Active, not recruiting Early Phase 1 Nader Sanai Started 2021Primary completion 2024-03 NCT05076513

    niraparib

    …on who have had a prior resection of histologically diagnosed WHO grade II-IV glioma with IDH1 or IDH2 mutation and ATRX loss.

    Glioblastoma, Glioblastoma Multiforme, Glioma, GBM

  129. Residual IDH1-Mutant Tumor Cell Quantification Study

    Not yet recruiting No phase NYU Langone Health Starts 2027Primary completion 2032-08 NCT07219199

    Newly diagnosed diffuse glioma with either (a) radiographic features consistent with IDH-mutant glioma or (b) prior molecular confirmation of an IDH mutation

    Glioma

  130. Monitoring of Neurological Symptoms, Treatment Tolerance, and Quality of Life Using the Resilience PRO Electronic Patient-reported Outcome Application in Patients With IDH-mutated Glioma

    Not yet recruiting No phase Assistance Publique - Hôpitaux de Paris Started 2026Primary completion 2029-09 NCT07439302

    Diagnosed with grade 2-4 glioma with IDH1/2 mutation

    Oncology, Glioma

  131. Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma

    Not yet recruiting No phase Huashan Hospital Started 2026Primary completion 2027-06 NCT07469735

    vorasidenib FDA EU

    Histologically or molecularly confirmed WHO 2021 grade 2 or 3 IDH1/2-mutant diffuse glioma with recurrent or residual disease

    Glioma, Diffuse Glioma, Recurrent Gliomas

  132. A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1/2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study)

    Active, not recruiting No phase Servier (Tianjin) Pharmaceutical Started 2025Primary completion 2028-04 NCT06969352

    vorasidenib FDA EU

    Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation

    Gliomas

  133. High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study

    Recruiting No phase Dana-Farber Cancer Institute Started 2023Primary completion 2026-09 NCT05740839

    Histologically diagnosed brain tumor during childhood, or currently diagnosed with an IDH-mutant glioma (diagnosed \> 18 years).

    Pediatric Brain Tumor

  134. Cryoablation of Brain Neoplasm

    Enrolling by invitation No phase Erasmus Medical Center Started 2023Primary completion 2025-02 NCT06753617

    Astrocytoma, IDH mutant 2.

    Brain Neoplasm, Brain Metastases, Glioma, Meningioma

  135. PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas

    Recruiting No phase Oslo University Hospital Started 2022Primary completion 2030-12 NCT05190172

    IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.

    Oligodendroglioma, Oligodendroglioma, Anaplastic, Diffuse Astrocytoma, IDH-Mutant

  136. Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas

    Recruiting No phase University of California, San Francisco Started 2019Primary completion 2027-03 NCT03948490

    Have a presumed lower grade IDH-mutated primary brain tumor and either be undergoing definitive surgery or have had surgical rese…

    Low-grade Glioma

  137. Proton vs. Photon Radiotherapy for Patients With WHO Grade 2-3 Glioma

    Recruiting No phase University Hospital, Essen Started 2019Primary completion 2027-12 NCT07750457

    Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the loc…

    Glioma

  138. Proton Radiation Therapy for Gliomas

    Active, not recruiting No phase Massachusetts General Hospital Started 2011Primary completion 2027-05 NCT01358058

    …ologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion

    Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion

  139. Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

    Recruiting No phase Memorial Sloan Kettering Cancer Center Started 2009Primary completion 2027-09 NCT00870129

    … of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation

    Brain Cancer, Glioma

  140. Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, IDH Wildtype, MGMT-Unmethylated Glioblastoma

    Recruiting Phase 3 NRG Oncology Started 2026Primary completion 2030-01 NCT07452458

    temozolomide

    IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e.

    Broad match: IDH1/2 mutationGlioblastoma, IDH-Wildtype, MGMT-Unmethylated Glioblastoma

  141. Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases

    Recruiting Phase 3 The Netherlands Cancer Institute Started 2025Primary completion 2028-07 NCT06888817

    bevacizumabdexamethasone

    …osis of high-grade diffuse glioma according to WHO 2021 criteria, including: astrocytoma, IDH-mutant, grade 3-4

    Broad match: IDH1/2 mutationRadiation Necrosis, High Grade Glioma (III or IV), Brain Metastasases, Radiation Toxicity

  142. Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)

    Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2026Primary completion 2030-10 NCT07209189

    toripalimabcisplatincarboplatindocetaxel

    …sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).

    Broad match: IDH1/2 mutationHead and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancer

  143. Pharmacoscopy for Patients With Refractory Primary Brain Tumors

    Recruiting Phase 2 University of Zurich Started 2026Primary completion 2028-09 NCT06804655

    Refractory glioblastoma, isocitrate dehydrogenase (IDH)-mutant astrocytoma or oligodendroglioma, histone-mutant glioma, ependymoma, medulloblastoma, men…

    Broad match: IDH1/2 mutationBrain (Nervous System) Cancers, Glioblastoma, Glioma, Ependymoma

  144. Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors

    Recruiting Phase 1/2 Centre Leon Berard Started 2025Primary completion 2029-10 NCT07243470

    Tarlatamabtemozolomide

    Histologically proven diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or other high-grade CNS tumors.

    Broad match: IDH1/2 mutationGlioma, CNS Tumor, Adult, CNS Tumor, Childhood

  145. Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention

    Recruiting Phase 2 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Started 2024Primary completion 2027-10 NCT06686108

    azacitidinedecitabinevenetoclax

    …sk subgroups based on NGS definition: PI3K signaling pathway/NRAS, KRAS/TP53/IKZF1/DNTM3A/IDH1, IDH2 gene mutation with or without NOTCH1, FBXW7/PHF6/EP300 gene mutation.

    Broad match: IDH1/2 mutationT-cell Acute Lymphoblastic Leukemia, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Relapse

  146. Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2017Primary completion 2027-07 NCT03220646

    abemaciclib

    Histologically confirmed IDH mutant glioma, meningioma, schwanomma, PCNSL, ependymoma, or other Primary Brain Tumors that hav…

    Broad match: IDH1/2 mutationBrain Tumor

  147. Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

    Recruiting Phase 1/2 Cerenome Started 2015Primary completion 2027-04 NCT01906385

    Rhenium Liposome Treatment

    … III/IV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4

    Broad match: IDH1/2 mutationGlioma

  148. HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)

    Recruiting No phase Dartmouth-Hitchcock Medical Center Started 2025Primary completion 2028-07 NCT06930846

    … with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT …

    Broad match: IDH1/2 mutationBrain Cancer, Brain Tumor, Brain Neoplasms, Primary Brain Tumor

  149. Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients

    Recruiting No phase Royal Marsden NHS Foundation Trust Started 2025Primary completion 2026-12 NCT07673861

    Identified targetable mutation (IDH1 mutation/HER2 amplification/FGFR2 fusion or rearrangement/NTRK fusion/BRAF V600E mutation/MMR defi…

    Broad match: IDH1/2 mutationNon Small Cell Lung Cancer, Gastrointestinal Stromal Tumor (GIST), Colorectal Cancer, Biliary Tract Cancer