FLT3 mutation (ITD/TKD)

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.

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.

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.

20 of 20 drugs shown

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.

Companies

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

1. Sunshine Lake Pharma 2
2. Daiichi Sankyo 2
3. Kura Oncology 2
4. Shijiazhuang Yiling Pharmaceutical 1
5. Novartis 1
6. Astellas 1
7. CSPC 1
8. Sumitomo Pharma America 1
9. Lomond Therapeutics Holdings 1
10. Meryx 1
11. Oryzon Genomics 1
12. Hrain Biotechnology 1

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention FLT3 mutation (ITD/TKD) rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

61 of 187 trials shown

1. FLT3-ITD Targeted Therapy in Fit AML Patients

   Not yet recruiting Phase 2/3 European Organisation for Research and Treatment of Cancer - EORTC Started 2026Primary completion 2028-10 NCT07425808

   gilteritinib FDA EUvenetoclaxazacitidineLocal standard of care (SOC)

   FLT3-ITD mutation as per local IVDR-compliant testing.

   AML (Acute Myeloid Leukemia)

2. MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib

   Recruiting Phase 3 The First Affiliated Hospital of Soochow University Started 2026Primary completion 2028-05 NCT07463651

   gilteritinib FDA EUsorafenib

   …ogy, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;

   Acute Myeloid Leukemia (AML), FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantation (HCT), Maintenance Therapy

3. VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML

   Not yet recruiting Phase 3 Institute of Hematology & Blood Diseases Hospital Started 2026Primary completion 2029-02 NCT07407140

   gilteritinib FDA EUazacitidinevenetoclaxcytarabinedaunorubicinidarubicinRe-induction TherapyConsolidation TherapyMaintenance Therapy

   Documented FLT3-ITD or FLT3-TKD mutation by PCR or NGS

   AML, Adult

4. A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)

   Not yet recruiting Phase 3 Shijiazhuang Yiling Pharmaceutical Started 2023Primary completion 2027-07 NCT05876832

   XY0206Salvage Chemotherapy

   Patient is positive for FLT3-ITD mutation in bone marrow or whole blood.

   Status may be outdated, last updated 2023-05-26Acute Myeloid Leukemia With FLT3/ITD Mutation

5. HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

   Recruiting Phase 3 Sunshine Lake Pharma Started 2023Primary completion 2027-11 NCT05586074

   Clifutinibcytarabineazacitidinedecitabineidarubicinpegfilgrastimfludarabine

   Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab

   Leukemia, Acute Myeloid (AML)

6. A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

   Recruiting Phase 3 Children's Oncology Group Started 2020Primary completion 2029-06 NCT04293562

   Asparaginase Erwinia chrysanthemicytarabinedaunorubicinDexrazoxane Hydrochlorideetoposidegemtuzumab ozogamicingilteritinib FDA EUCPX-351methotrexatemitoxantroneTherapeutic Hydrocortisone

   …to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

   Acute Myeloid Leukemia

7. A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

   Active, not recruiting Phase 3 Stichting Hemato-Oncologie voor Volwassenen Nederland Started 2019Primary completion 2025-10 NCT04027309

   gilteritinib FDA EUmidostaurin FDA EU

   … blasts-2 (EB2) defined according to WHO criteria (appendix A), with centrally documented FLT3 gene mutation (either TKD or ITD or both).

   Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2

8. Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

   Not yet recruiting Phase 2 National Cancer Institute (NCI) Starts 2027Primary completion 2027-12 NCT07862517

   azacitidinecytarabinedaunorubicinquizartinib FDA EUvenetoclax

   Patient must have newly diagnosed acute myeloid leukemia (AML) with FLT3 ITD mutation as assessed by central myeloMATCH testing with variant allele frequency (VAF) ov…

   Acute Myeloid Leukemia

9. Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML

   Recruiting Phase 2 First Affiliated Hospital of Zhejiang University Started 2026Primary completion 2028-12 NCT07259707

   gilteritinib FDA EU

   Newly diagnosed acute myeloid leukemia with FLT3-ITD mutation according to the European LeukemiaNet (ELN) 2022 diagnostic criteria (no VAF req…

   Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia, Fit Patients

10. Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia

    Not yet recruiting Phase 1/2 University Hospital, Bordeaux Started 2026Primary completion 2027-09 NCT07726576

    venetoclaxmidostaurin FDA EU

    Documented FLT3 gene mutation (-TKD D835 or I836 or -ITD or both) FLT3-ITD is assessed by DNA fragment analysis.

    Leukemia, Myeloid, Acute

11. Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML

    Recruiting Phase 2 OHSU Knight Cancer Institute Started 2025Primary completion 2027-10 NCT06504459

    azacitidinecladribinecytarabinevenetoclax

    …ization (WHO), or active signaling mutated AML defined as AML with mutation(s) to N/KRAS, FLT3 ITD/TKD, NF1, PTPN11 or CBL

    Acute Monocytic Leukemia, Acute Myeloid Leukemia

12. Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

    Recruiting Phase 2 Daiichi Sankyo Started 2025Primary completion 2028-06 NCT06824168

    quizartinib FDA EU

    Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow …

    Acute Myeloid Leukemia, Leukemia

13. Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

    Recruiting Phase 2 Technische Universität Dresden Started 2025Primary completion 2029-04 NCT06696183

    gilteritinib FDA EUvenetoclaxazacitidine

    FLT3 mutation at initial diagnosis

    AML - Acute Myeloid Leukemia

14. Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

    Not yet recruiting Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto Started 2025Primary completion 2028-08 NCT06667973

    gilteritinib FDA EU

    Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

    Acute Myeloid Leukemia, FLT3 Gene Mutation, Adult AML, Diagnosis

15. A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2024Primary completion 2027-10 NCT06235801

    gilteritinib FDA EUMomelotinib

    a) Adults ≥18 years with relapsed/refractory FLT3-mutated AML.

    Myeloid Leukemia

16. Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia

    Recruiting Phase 2 French Innovative Leukemia Organisation Started 2024Primary completion 2026-10 NCT06022003

    azacitidinegilteritinib FDA EU

    Presence of FLT3-mutation(s) at inclusion: in case of FLT3-ITD, the ITD/wt ratio must be \> 0.05

    AML, Adult, Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation

17. CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

    Recruiting Phase 2 Princess Maxima Center for Pediatric Oncology Started 2024Primary completion 2028-06 NCT06262438

    quizartinib FDA EUetoposideDexrazoxanemitoxantronecytarabinemethotrexatedaunorubicinfludarabine

    FLT3-ITD+ and wild-type NPM1:

    Acute Myeloid Leukemia in Children

18. Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2024Primary completion 2029-05 NCT06317649

    azacitidinegilteritinib FDA EUvenetoclax

    Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol

    Acute Myeloid Leukemia

19. A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

    Active, not recruiting Phase 2 Centre Antoine Lacassagne Started 2023Primary completion 2028-07 NCT05199051

    cytarabinegilteritinib FDA EUgemtuzumab ozogamicin

    Presence of a FLT3-ITD mutation (allelic ratio ≥0.05 at last evaluation)\* or a FLT3 TKD mutation

    AML, Leukaemia (Acute Myeloid)

20. A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

    Active, not recruiting Phase 1/2 Astellas Started 2023Primary completion 2028-07 NCT05520567

    gilteritinib FDA EUvenetoclaxazacitidine

    Participant is positive for FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication \[ITD\] and/or tyrosine kinase domain \[TKD\] \[D835/I836\] …

    Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia

21. A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

    Recruiting Phase 1/2 Sunshine Lake Pharma Started 2022Primary completion 2027-12 NCT05133882

    Clifutinib Besylate

    the extension phase requires the subject to be positive for the FLT3-ITD mutation.

    Acute Myeloid Leukemia, Adult

22. A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

    Recruiting Phase 1/2 Sumitomo Pharma America Started 2022Primary completion 2027-06 NCT04988555

    enzomenibazolesvenetoclaxgilteritinib FDA EUazacitidineIntensive chemotherapy with 7 + 3

    Have MLLr or NPM1m AND any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836.

    Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, Multiple Myeloma, Myelodysplastic Syndromes

23. ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2021Primary completion 2028-01 NCT05010122

    decitabinegilteritinib FDA EUvenetoclax

    Phase I cohort: Adults \>= 18 years with relapsed/refractory FLT3-mutated AML or myelodysplastic syndrome (MDS) that is intermediate-2 or high-risk by the Internat…

    Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

24. SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

    Recruiting Phase 1/2 CSPC Started 2021Primary completion 2024-10 NCT05445154

    SKLB1028 Dose Escalation

    Subjects who are positive for FLT3 mutations by central laboratory;

    Status may be outdated, last updated 2022-07-06Newly Diagnosed Acute Myeloid Leukemia (AML)

25. Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2020Primary completion 2027-12 NCT04493138

    azacitidinequizartinib FDA EU

    Detectable FLT3-ITD mutation in bone marrow and/or peripheral blood, or presence of CBL exon 8 or 9 deletions…

    Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Chronic Myelomonocytic Leukemia

26. Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

    Recruiting Phase 1/2 Technische Universität Dresden Started 2020Primary completion 2027-04 NCT04385290

    cytarabinedaunorubicinmidostaurin FDA EUgemtuzumab ozogamicin

    FLT3-ITD or

    Acute Myeloid Leukemia

27. A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

    Active, not recruiting Phase 2 Novartis Started 2019Primary completion 2029-05 NCT03591510

    midostaurin FDA EUfludarabinecytarabinedaunorubicinidarubicinmitoxantroneetoposide

    …Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

    FLT3-mutated Acute Myeloid Leukemia

28. Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2019Primary completion 2028-09 NCT04140487

    azacitidinegilteritinib FDA EUvenetoclax

    Phase I cohort: Adults ≥ 18 years with relapsed/refractory FLT3-mutated AML or CMML or other MDS/MPN that is intermediate-2 or high-risk by the International Pro…

    Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Refractory Acute Myeloid Leukemia

29. Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

    Active, not recruiting Phase 1/2 Daiichi Sankyo Started 2018Primary completion 2027-05 NCT03793478

    quizartinib FDA EUfludarabinecytarabineIntrathecal (IT) triple chemotherapy prophylaxisetoposide

    Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as defined in the protocol

    Acute Myeloid Leukemia

30. A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia

    Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2025Primary completion 2028-05 NCT07011004

    Cytokine Induced Memory-Like Natural Killer CellsAtezolizumbCIML-NK cell therapy

    Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT…

    Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse

31. Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia

    Recruiting Phase 1 Lomond Therapeutics Holdings Started 2024Primary completion 2026-01 NCT06366789

    ZE46-0134

    Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing.

    AML With Gene Mutations

32. SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

    Recruiting Phase 1 Uma Borate Started 2024Primary completion 2027-01 NCT06222580

    gilteritinib FDA EUrevumenib

    …afety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed/Refractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phas…

    Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Recurrent Acute Myeloid Leukemia

33. Revumenib in Combination With 7+3 + Midostaurin in AML

    Recruiting Phase 1 Richard Stone, MD Started 2024Primary completion 2027-03 NCT06313437

    revumenibmidostaurin FDA EUcytarabinedaunorubicin

    Presence of FLT3-ITD and/or TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood

    Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML

34. CIML NK Cells With Venetoclax for AML

    Recruiting Phase 1 Dana-Farber Cancer Institute Started 2024Primary completion 2026-11 NCT06152809

    Cytokine-Induced Memory-like Natural Killer Cellsaldesleukinvenetoclax

    …ditional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD

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

35. Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

    Recruiting Phase 1 Kura Oncology Started 2024Primary completion 2026-12 NCT06001788

    ziftomenibfludarabineidarubicincytarabinegilteritinib FDA EUGranulocyte colony-stimulating factor

    Has a documented FLT3 mutation (cA-3 only).

    AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar

36. 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

    gilteritinib FDA EUivosidenibenasidenib

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

    Acute Myeloid Leukemia (AML)

37. A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

    Recruiting Phase 1 Kura Oncology Started 2023Primary completion 2030-04 NCT05735184

    ziftomenibvenetoclaxazacitidinedaunorubicincytarabinequizartinib FDA EU

    Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment

    Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1

38. Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

    Active, not recruiting Phase 1 Oryzon Genomics Started 2022Primary completion 2026-01 NCT05546580

    Iadademstatgilteritinib FDA EU

    Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain…

    Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory

39. Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL

    Recruiting Phase 1 Meryx Started 2022Primary completion 2026-07 NCT04872478

    MRX-2843

    For the FLT3ITD expansion cohort at RP2D, the FLT3ITD+ patients should have previously been treated with …

    Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia

40. Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

    Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2022Primary completion 2027-02 NCT05024552

    gilteritinib FDA EUCPX-351daunorubicincytarabine

    FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one …

    Acute Myeloid Leukemia With FLT3/ITD Mutation

41. Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

    Recruiting Phase 1 OHSU Knight Cancer Institute Started 2021Primary completion 2026-12 NCT04659616

    cytarabinedaunorubicinpemigatinib

    Patients with known favorable risk AML (2022 European Leukemia Net \[ELN\] Guidelines) or FLT3 mutations should not be pre-screened.

    Acute Myeloid Leukemia

42. Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

    Active, not recruiting Phase 1 Northwestern University Started 2018Primary completion 2023-12 NCT03513484

    azacitidineNintedanib

    FLT3-ITD (internal tandem duplication)

    Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication, Recurrent Adult Acute Myeloid Leukemia

43. Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia

    Recruiting Early Phase 1 Hrain Biotechnology Started 2022Primary completion 2025-12 NCT06760260

    Human Derived anti-CI135 CAR-T Injection

    Positive for FLT3 mutation confirmed by leukemia cell genetic testing, or FLT3 expression ≥35%;

    Acute Myeloid Leukemia (AML)

44. Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality

    Recruiting Phase 4 Virginia Commonwealth University Started 2024Primary completion 2027-01 NCT06370000

    azacitidine

    …pean Leukemia Net (ELN), MRD+ CR, slow clearance of MRD) or any AML phenotype (aside from FLT3+ and APL) in CR2 and beyond

    Broad match: FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia

45. Umbilical Cord Blood Consolidation for Older Adults With Intermediate- and High-Risk AML

    Not yet recruiting Phase 3 Shanghai Jiao Tong University School of Medicine Started 2026Primary completion 2029-10 NCT07761702

    Unrelated Umbilical Cord Blood Infusioncytarabine

    Common gene mutations include NPM1, FLT3-ITD, CEBPA and c-kit;

    Broad match: FLT3 mutation (ITD/TKD)AML (Acute Myelogenous Leukemia)

46. Molecular Genetics Guide the Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation

    Recruiting Phase 2/3 Ruijin Hospital Started 2025Primary completion 2030-03 NCT06972641

    decitabinesorafenibAvastinibvenetoclax

    ARM2 Initial bone marrow gene II sequencing showed FLT3-ITD mutation with or without NPM1 mutation, no TP53 mutation, and no AML/MR.

    Broad match: FLT3 mutation (ITD/TKD)AML, MDS

47. Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

    Active, not recruiting Phase 3 Children's Oncology Group Started 2023Primary completion 2026-06 NCT05457556

    BusulfancyclophosphamidefludarabineLapine T-Lymphocyte Immune GlobulinmelphalanmethotrexateMycophenolate MofetilrituximabtacrolimusThiotepa

    FLT3/ITD+ with allelic ratio \> 0.1 without bZIP CEBPA, NPM1

    Broad match: FLT3 mutation (ITD/TKD)Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome

48. Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

    Recruiting Phase 2/3 University Hospital, Angers Started 2015Primary completion 2025-07 NCT02416388

    idarubicindaunorubicincytarabineCyclosporinemethotrexateMycophenolic acid (MPA)vosaroxindexamethasonevenetoclax

    Genetic mutation testing of the FLT3 (FLT3-ITD ou FLT3-TKD) gene, performed in local or central laboratory

    Broad match: FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia (AML)

49. Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients

    Not yet recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2026Primary completion 2028-03 NCT07505160

    LisafotoclaxdecitabineHomoharringtonine

    …nce/progression: ≥1 log increase or persistent positivity of driver gene mutations (e.g., FLT3-ITD, IDH1/2, NPM1) by quantitative PCR or NGS compared to best response;

    Broad match: FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia (AML)

50. Menin-Inhibitor Targeted Maintenance in AML

    Not yet recruiting Phase 2 Center for International Blood and Marrow Transplant Research Started 2026Primary completion 2031-06 NCT07563010

    revumenib

    NPM1-mutated (NPM1m) AML (Including FLT3-ITD or TKD co-mutation) 3.

    Broad match: FLT3 mutation (ITD/TKD)Relapsed Adult AML, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Transplant-Related Hematologic Malignancy

51. Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant

    Recruiting Phase 2 University of Alabama at Birmingham Started 2025Primary completion 2028-08 NCT06265584

    tacrolimusmethotrexate

    …ular features (≥ 4 clonal abnormalities, or monosomal karyotype, inv(3)/t(3;3) or, EV11+, FLT3-ITD (+) without MPN1, P53 mutation positive, ASXL1+, mutant RUNX1.

    Broad match: FLT3 mutation (ITD/TKD)Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders

52. 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

    olutasidenibcladribinevenetoclaxgilteritinib FDA EURuxolitinibcytarabine

    …nted co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R.

    Broad match: FLT3 mutation (ITD/TKD)Targeted Therapy, IDH1-Mutated Malignancies, Mutations

53. Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases

    Recruiting Phase 2 University of Florida Started 2024Primary completion 2027-05 NCT05800210

    AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)

    Broad match: FLT3 mutation (ITD/TKD)Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndromes

54. Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2024Primary completion 2027-12 NCT05554393

    azacitidinecytarabinedaunorubicinvenetoclax

    AML with FLT3-ITD mutation

    Broad match: FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia

55. TMLI/Fludarabine/Melphalan Conditioning for Allogeneic Transplantation in High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia.

    Not yet recruiting Phase 2 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Started 2024Primary completion 2028-10 NCT06602323

    TMLI/Flu/Mel

    …d by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing (in the case of fms-like tyrosine kinase-3 internal tandem duplication-mutated AML).

    Broad match: FLT3 mutation (ITD/TKD)Status may be outdated, last updated 2024-09-19Myelodysplastic Syndromes, Acute Myeloid Leukemia

56. AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

    Recruiting Phase 2 Mitchell Cairo Started 2021Primary completion 2026-12 NCT04099966

    alpha beta depletion

    AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)

    Broad match: FLT3 mutation (ITD/TKD)Acute Leukemia, Severe Aplastic Anemia, Non-hodgkin Lymphoma, Hodgkin Lymphoma

57. TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies

    Active, not recruiting Phase 2 St. Jude Children's Research Hospital Started 2019Primary completion 2024-08 NCT03849651

    cyclophosphamidefludarabineThiotepamelphalanpegfilgrastimMesnaATG (rabbit)BlinatumomabTCRα/β+CD19+CD45RA-depleted DLI

    …1;22), MRD \> 0.1% after two cycles of induction, MRD \> 1% after one cycle of induction, FLT3-ITD in combination with NUP98-NSD1 fusion or WT1 mutation, any high risk cytogenetics such as…

    Broad match: FLT3 mutation (ITD/TKD)Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), NK-Cell Leukemia

58. Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

    Active, not recruiting Phase 2 University of Illinois at Chicago Started 2017Primary completion 2026-11 NCT03121014

    fludarabineBusulfanATGtacrolimusmethotrexate

    Poor risk molecular features including presence of FLT3 internal tandem duplication mutation.

    Broad match: FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia, Myelodysplastic Syndromes

59. KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children

    Enrolling by invitation Phase 2 Michael Pulsipher Started 2015Primary completion 2025-11 NCT02646839

    High-risk AML defined as monosomy 5, del 5q, monosomy 7, M6, M7, t(6;9), FLT3-ITD, or patients who have greater than or equal to 25% blasts by morphology after induction, …

    Broad match: FLT3 mutation (ITD/TKD)Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndromes

60. Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

    Recruiting Phase 1 City of Hope Medical Center Started 2024Primary completion 2028-04 NCT06575296

    revumenib

    FLT3-ITD co-mutation

    Broad match: FLT3 mutation (ITD/TKD)Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

61. T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia

    Active, not recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2018Primary completion 2027-05 NCT03531736

    Antithymocyte globulin (Rabbit)fludarabinecyclophosphamiderituximab

    Normal karyotype with mutations of FLT3, RUNX1, TP53 mutation, ASXL1 or any others that are considered to be high risk

    Broad match: FLT3 mutation (ITD/TKD)Myeloid Diseases

No trials match these filters.