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Profile Name FLT3 mutant
Gene Variant Detail

FLT3 mutant (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 mutant acute myeloid leukemia sensitive Cytarabine + Venetoclax Guideline Actionable Venclexta (venetoclax) in combination with Cytosar-U (cytarabine) is included in guidelines for adult patients with acute myeloid leukemia harboring a FLT3 mutation (NCCN.org). detail...
FLT3 mutant acute myeloid leukemia sensitive Cytarabine + Venetoclax Phase Ib/II Actionable In a Phase I/II trial, Venclexta (venetoclax) in combination with low-dose cytarabine resulted in complete remission or complete remission with incomplete count recovery in 44% (7/16) of patients with acute myeloid leukemia harboring FLT3 mutations who were ineligible for intensive chemotherapy (ASH Annual Meeting, Dec 2018, Abstract 284; NCT02287233). detail...
FLT3 mutant acute myeloid leukemia sensitive Azacitidine + Midostaurin Phase Ib/II Actionable In a Phase Ib/II trial, acute myeloid leukemia patients harboring a FLT3 mutation demonstrated an improved remission duration when treated with the combination therapy, Rydapt (midostaurin) and Vidaza (azacitidine) (PMID: 25530214). 25530214
FLT3 mutant acute myeloid leukemia sensitive UNC2025 Preclinical Actionable In a preclinical study, UNC2025 inhibited FLT3 activation and growth of acute myeloid leukemia cells harboring a FLT3-ITD mutation in culture (PMID: 25068800). 25068800
FLT3 mutant acute myeloid leukemia sensitive Selinexor + Sorafenib Phase Ib/II Actionable In a Phase I/II trial, combination of Selinexor and Nexavar (sorafenib) treatment resulted in complete remission in 29% (4/14) and more than 50% blast reduction in 14% (2/14) of patients with acute myeloid leukemia harboring FLT3 ITD and/or D835 mutations (ASH, 59th Annual Meeting and Exposition, Dec 2017, Abstract 1344; NCT01607892). detail...
FLT3 mutant acute myeloid leukemia sensitive Zotiraciclib Preclinical - Cell line xenograft Actionable In a preclinical study, Zotiraciclib (TG02) inhibited growth of FLT3-mutated acute myeloid leukemia cells in culture, resulted in complete tumor regression in cell line xenograft animal models (PMID: 21860433). 21860433
FLT3 mutant acute myeloid leukemia sensitive Decitabine + Venetoclax Guideline Actionable Venclexta (venetoclax) in combination with Dacogen (decitabine) is included in guidelines for adult patients with acute myeloid leukemia harboring a FLT3 mutation (NCCN.org). detail...
FLT3 mutant acute myeloid leukemia sensitive Gilteritinib Phase Ib/II Actionable In a Phase I/II trial, treatment with Gilteritinib (ASP2215) resulted in an overall response rate of 49% (93/191) in patients with relapsed or refractory acute myeloid leukemia harboring FLT3 mutations, compared to 12% (7/58) in patients with wild-type FLT3 (PMID: 28645776; NCT02014558). detail... 28645776
FLT3 mutant acute myeloid leukemia sensitive Gilteritinib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD), D835, or I836 mutation (FDA.gov; NCT02421939). detail... detail...
FLT3 mutant acute myeloid leukemia predicted - sensitive ERAS-601 + Gilteritinib Preclinical Actionable In a preclinical study, the combination of ERAS-601 and Xospata (gilteritinib) demonstrated synergy, resulting in decreased viability of acute myeloid leukemia cells harboring FLT3 mutations in culture and inhibition of tumor growth in in vivo models (Cancer Res (2022) 82 (12_Supplement): 3345). detail...
FLT3 mutant acute myeloid leukemia sensitive E6201 Preclinical Actionable In a preclinical study, acute myeloid leukemia cell lines harboring FLT3 mutations demonstrated increased sensitivity to E6201 induced growth inhibition and apoptosis in culture compared to FLT3 wild-type cells (PMID: 26822154). 26822154
FLT3 mutant acute myeloid leukemia sensitive Cytarabine + Daunorubicin + Midostaurin Phase Ib/II Actionable In a Phase Ib clinical trial, Rydapt (midostaurin) treatment after Daunorubicin and Cytosar-U (cytarabine) induction resulted in complete remission in 92% (12/13) of acute myeloid leukemia patients carrying FLT3 mutations, although overall survival rate was similar to patients with wild-type FLT3 (PMID: 22627678). 22627678
FLT3 mutant acute myeloid leukemia sensitive Cytarabine + Daunorubicin + Midostaurin FDA approved - Has Companion Diagnostic Actionable In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (HR=0.78, p=0.009) and event-free survival (HR=0.78, p=0.002) in patients with FLT3-mutant (ITD, D835X, and I836X mutations) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114; NCT00651261). 28644114 detail... detail...
FLT3 mutant acute myeloid leukemia sensitive Crenolanib Phase I Actionable In a Phase I trial, Crenolanib treatment resulted in complete response (CR) in 39% (7/18), partial response (PR) in 11% (2/18), and an overall survival (OS) of 234 days in AML patients harboring FLT3 mutations (D835X, ITD, or both) that received no prior therapy, and CR in 17% (6/36), PR in 14% (5/36), and OS of 94 days in those progressed on TKIs (J Clin Oncol 34, 2016 (suppl; abstr 7008)). detail...
FLT3 mutant acute myeloid leukemia sensitive Azacitidine + Venetoclax Guideline Actionable Venclexta (venetoclax) in combination with Vidaza (azacitidine) is included in guidelines for adult patients with acute myeloid leukemia harboring a FLT3 mutation (NCCN.org). detail...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02487459 Phase I Rivogenlecleucel Rimiducid Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies Withdrawn USA 0
NCT05028751 Phase Ib/II Gilteritinib + Lanraplenib A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) Recruiting USA 0
NCT05279859 Phase Ib/II ERAS-007 + Gilteritinib A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies (HERKULES-4) Withdrawn USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) Recruiting USA 0
NCT02530476 Phase Ib/II Selinexor + Sorafenib Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia Completed USA 0
NCT03825796 Phase II CPX-351 + Enasidenib Cytarabine + Enasidenib Enasidenib CPX-351 Plus Enasidenib for Relapsed AML Suspended USA 0
NCT03934372 Phase Ib/II Ponatinib Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors Recruiting ITA | FRA | ESP | DEU | BEL 4
NCT03070093 Expanded access Gilteritinib Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD) Approved for marketing USA | CAN 1
NCT03613532 Phase I Busulfan + Fludarabine + Venetoclax Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN Recruiting USA 0
NCT04409639 Phase II Cobimetinib Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations (CONCERTO) Recruiting USA 0
NCT02381548 Phase I Adavosertib + Belinostat Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia Terminated USA 0
NCT04982354 Phase Ib/II Busulfan + CPX-351 + Fludarabine + Melphalan + Midostaurin Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Recruiting USA 0
NCT02543879 Phase I FT-1101 Azacitidine + FT-1101 Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Completed USA 0
NCT02624570 Phase I Midostaurin Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy. No longer available USA 0
NCT03709758 Phase I Cytarabine + Daunorubicin + Venetoclax Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naive AML Suspended USA 0
NCT01831726 Phase II Dovitinib Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Completed USA 0
NCT04659616 Phase I Cytarabine + Pemigatinib Cytarabine + Daunorubicin + Pemigatinib Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia Recruiting USA 0
NCT02315625 Phase II Everolimus Sunitinib Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery Terminated USA 0
NCT02634827 Phase II Decitabine + Midostaurin Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation Terminated USA 0
NCT03194685 Phase Ib/II FF-10101 Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Completed USA 0
NCT02323607 Phase I Cytarabine + Daunorubicin + Pacritinib Decitabine + Pacritinib Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations Completed USA 0
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) Recruiting CAN 0
NCT02756962 Phase II Midostaurin Cytarabine Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance Recruiting USA 0
NCT03836209 Phase II Cytarabine + Daunorubicin + Gilteritinib Cytarabine + Daunorubicin + Midostaurin Cytarabine Midostaurin Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia Recruiting USA 0
NCT03701295 Phase Ib/II Azacitidine + Pinometostat Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement Completed USA 0
NCT02400281 Phase Ib/II Azacitidine Crenolanib Cytarabine + Idarubicin Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients Completed USA 0
NCT02727803 Phase II anti-thymocyte globulin + Fludarabine + haNK cells + Melphalan anti-thymocyte globulin + Cyclophosphamide + Fludarabine + haNK cells + Rituximab anti-thymocyte globulin + Busulfan + Clofarabine + Fludarabine + haNK cells Personalized NK Cell Therapy After Chemotherapy and Cord Blood Transplant in Treating Patients With Myelodysplastic Syndrome, Leukemia, Lymphoma or Multiple Myeloma Recruiting USA 0
NCT02270788 Phase I Cytarabine + Leucovorin + Methotrexate Crenolanib + Sorafenib Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies Completed USA 0
NCT04616248 Phase I CDX-1140 + CDX-301 + Poly ICLC Radio-immunotherapy (CDX-301, Radiotherapy, CDX-1140 and Poly-ICLC) for the Treatment of Unresectable or Metastatic Breast Cancer Patients Not yet recruiting USA 0
NCT02356159 Phase Ib/II Cytarabine + Fludarabine Palifermin Prednisone Filgrastim Methotrexate + Sirolimus + Tacrolimus Doxorubicin + Etoposide + Fludarabine + Vincristine Sulfate Cyclophosphamide + Fludarabine Rituximab Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Recruiting USA 0
NCT02747537 Phase II Irinotecan + Sorafenib Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan Withdrawn 0
NCT02829840 Phase Ib/II Azacitidine + Ponatinib Dose-Escalation Study of Ponatinib, a FLT3 Inhibitor, With and Without Combination of 5-Azacytidine, in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML) Withdrawn 0
NCT04536077 Phase II CDX-1140 + CDX-301 CDX-1140 Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients Recruiting USA 0
NCT03114228 Expanded access Midostaurin An Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) No longer available CAN 0
NCT02418000 Phase Ib/II E6201 A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 Mutation Terminated USA 0
NCT00887068 Phase III Azacitidine Randomized Allogeneic Azacitidine Study Completed USA 0
NCT03591510 Phase II Cytarabine Cytarabine + Etoposide Cytarabine + Mitoxantrone Cytarabine + Fludarabine + Idarubicin Cytarabine + Daunorubicin + Fludarabine Cytarabine + Daunoxome + Fludarabine Midostaurin A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML Recruiting USA | ITA | DEU | AUT 9
NCT04491084 Phase Ib/II CDX-1140 + CDX-301 FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy (FLT3) Recruiting USA 0
NCT03730012 Phase Ib/II Atezolizumab + Gilteritinib A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) Completed USA 0
NCT04051996 Phase II Decitabine + Glasdegib GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia Terminated USA 0
NCT04801797 Phase II Azacitidine + Venetoclax Cytarabine + Idarubicin Cytarabine + Daunoxome Cytarabine + Daunorubicin Venetoclax + Azacitidine vs. Induction Chemotherapy in AML Recruiting USA 0
NCT02532231 Phase II Nivolumab Nivolumab in AML in Remission at High Risk for Relapse Active, not recruiting USA 0
NCT01883362 Phase II Midostaurin Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML Completed USA | CAN 0
NCT03913026 Phase II ECT-001 cord blood cells Mycophenolate mofetil Tacrolimus Cyclophosphamide + Fludarabine Cyclophosphamide + Fludarabine + Thiotepa UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia/Myelodysplasia Recruiting CAN 0
NCT02193152 Phase I Pazopanib Pazopanib in Molecularly Selected Patients With Advanced NSCLC Terminated USA 0
NCT04223596 Phase II Brigatinib Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (CUBIK) Active, not recruiting ESP 0
NCT03620318 Expanded access Crenolanib Individual Patient Compassionate Use of Crenolanib Available ITA 0
NCT04214249 Phase II Cytarabine + Daunorubicin Cytarabine Cytarabine + Idarubicin Pembrolizumab Cytarabine + Daunorubicin + Pembrolizumab Cytarabine + Pembrolizumab Cytarabine + Idarubicin + Pembrolizumab BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia Recruiting USA 0
NCT05010200 Phase I CDX-301 + PGV 001 + Poly ICLC PGV 001 + Poly ICLC The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting. (PGV-Prostate) Recruiting USA 0
NCT02723435 Phase II Midostaurin Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant Withdrawn 0
NCT02126553 Phase II Lenalidomide Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission Completed USA 0
NCT01338987 Phase II Tacrolimus Busulfan Methotrexate Leuprolide Cyclophosphamide Fludarabine Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation Completed USA 0
NCT04140487 Phase Ib/II Azacitidine + Gilteritinib + Venetoclax Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Recruiting USA 0
NCT03625505 Phase I Gilteritinib + Venetoclax A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia Completed USA 0