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OncoMatch/Leukemia — Acute Myeloid (AML)/FLT3

Leukemia — Acute Myeloid (AML)FLT3 Clinical Trials

35 recruiting trials·Updated daily from ClinicalTrials.gov

FLT3 mutations — internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations — are the most common recurrent alterations in AML, present in ~30% of patients and associated with high relapse risk. Midostaurin combined with induction chemotherapy is first-line standard for FLT3-mutant AML; gilteritinib is approved for relapsed/refractory disease. Trials investigate second-generation FLT3 inhibitors, triplet combinations with venetoclax, and post-transplant maintenance.

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Phase 2
NCT06317649Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)Phase 2218 US sitesNCT04988555A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)Phase 1/Phase 233 US sitesNCT06824168Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete RemissionPhase 29 US sitesNCT06265584Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell TransplantPhase 21 US siteNCT03661307Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic SyndromePhase 1/Phase 21 US siteNCT06504459Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AMLPhase 21 US siteNCT04140487Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative NeoplasmPhase 1/Phase 21 US siteNCT06158828Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AMLPhase 1/Phase 21 US siteNCT05010122ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic SyndromePhase 1/Phase 21 US site
Phase 1
NCT05735184A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AMLPhase 144 US sitesNCT05546580Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)Phase 113 US sitesNCT05756777A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)Phase 17 US sitesNCT06222580SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 MutationPhase 13 US sitesNCT06152809CIML NK Cells With Venetoclax for AMLPhase 12 US sitesNCT06313437Revumenib in Combination With 7+3 + Midostaurin in AMLPhase 12 US sitesNCT05558124CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AMLPhase 11 US site
8 international trials (no US sites)
NCT06696183Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive TreatmentPhase 2NCT05133882A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AMLPhase 1/Phase 2NCT07012447Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid MutationsPhase 2NCT05241106A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)Phase 2NCT05241093A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)Phase 2NCT06022003Study 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 LeukemiaPhase 2NCT07259707Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AMLPhase 2NCT04385290Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)Phase 1/Phase 2
Other Leukemia — Acute Myeloid (AML) biomarkers

Browse other molecular targets with active Leukemia — Acute Myeloid (AML) trials.

KMT2A (MLL)NPM1IDH1TP53RUNX1IDH2