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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 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 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 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 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 + 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...
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 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 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 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 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 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 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
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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
NCT04051996 Phase II Decitabine + Glasdegib GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia Active, not recruiting 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
NCT02747537 Phase II Irinotecan + Sorafenib Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan Withdrawn 0
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
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
NCT04062266 Phase II Azacitidine + Venetoclax Azacitidine and Venetoclax in Treating Patients With High Risk Acute Myeloid Leukemia in Remission Recruiting USA 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
NCT03194685 Phase Ib/II FF-10101 Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Recruiting USA 0
NCT04659616 Phase I Cytarabine + Pemigatinib Cytarabine + Daunorubicin + Pemigatinib Pemigatinib in Combination With Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia Recruiting 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 9
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
NCT04409639 Phase II Cobimetinib Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations (CONCERTO) Recruiting USA 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
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
NCT03825796 Phase II CPX-351 + Enasidenib Cytarabine + Enasidenib Enasidenib CPX-351 Plus Enasidenib for Relapsed AML Recruiting USA 0
NCT02723435 Phase II Midostaurin Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant Withdrawn 0
NCT00887068 Phase III Azacitidine Randomized Allogeneic Azacitidine Study Completed USA 0
NCT02487459 Phase I BPX-501 Rimiducid Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies Withdrawn 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
NCT02532231 Phase II Nivolumab Nivolumab in AML in Remission at High Risk for Relapse Recruiting USA 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
NCT02270788 Phase I Cytarabine + Leucovorin + Methotrexate Crenolanib + Sorafenib Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies 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
NCT04536077 Phase II CDX-1140 + CDX-301 CDX-1140 Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients Not yet recruiting USA 0
NCT02126553 Phase II Lenalidomide Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission 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) Recruiting 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
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 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
NCT03613532 Phase I Busulfan + Fludarabine + Venetoclax Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN 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
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) (CAPTUR) Recruiting CAN 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
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
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
NCT02193152 Phase I Pazopanib Pazopanib in Molecularly Selected Patients With Advanced NSCLC Terminated USA 0
NCT02756962 Phase II Midostaurin Cytarabine Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance Recruiting USA 0
NCT01831726 Phase II Dovitinib Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Completed 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
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
NCT02634827 Phase II Decitabine + Midostaurin Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation Terminated USA 0
NCT03709758 Phase I Cytarabine + Daunorubicin + Venetoclax Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naive AML Recruiting USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab 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 Recruiting USA 0