Missing content? – Request curation!
Request curation for specific Genes, variants, or PubMed publications.
Have questions, comments or suggestions? - Let us know!
Email us at : ckbsupport@jax.org
Profile Name | FLT3 mutant |
Gene Variant Detail | |
Relevant Treatment Approaches |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
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 |
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 |
NCT03934372 | Phase Ib/II | Ponatinib | Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias or Solid Tumors | Recruiting | ITA | FRA | ESP | DEU | BEL | 4 |
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 | Withdrawn | USA | 0 |
NCT02193152 | Phase I | Pazopanib | Pazopanib in Molecularly Selected Patients With Advanced NSCLC | Terminated | 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 |
NCT05279859 | Phase Ib/II | ERAS-007 + Gilteritinib | A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies (HERKULES-4) | Recruiting | 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 |
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 |
NCT03825796 | Phase II | CPX-351 + Enasidenib Cytarabine + Enasidenib Enasidenib | CPX-351 Plus Enasidenib for Relapsed AML | Suspended | USA | 0 |
NCT03620318 | Expanded access | Crenolanib | Individual Patient Compassionate Use of Crenolanib | Available | ITA | 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 |
NCT03613532 | Phase I | Busulfan + Fludarabine + Venetoclax | Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN | 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 |
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 |
NCT04409639 | Phase II | Cobimetinib | Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations (CONCERTO) | Recruiting | USA | 0 |
NCT03709758 | Phase I | Cytarabine + Daunorubicin + Venetoclax | Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naive AML | Suspended | USA | 0 |
NCT02487459 | Phase I | Rivogenlecleucel Rimiducid | Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies | Withdrawn | 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 |
NCT02126553 | Phase II | Lenalidomide | Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission | Completed | 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 |
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 |
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 |
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 |
NCT04982354 | Phase Ib/II | Busulfan + CPX-351 + Fludarabine + Melphalan + Midostaurin | Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia | Not yet recruiting | 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 |
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 | Recruiting | USA | 0 |
NCT02747537 | Phase II | Irinotecan + Sorafenib | Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan | Withdrawn | 0 | |
NCT02418000 | Phase Ib/II | E6201 | A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 Mutation | Terminated | 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 |
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 |
NCT00887068 | Phase III | Azacitidine | Randomized Allogeneic Azacitidine Study | 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 |
NCT02323607 | Phase I | Cytarabine + Daunorubicin + Pacritinib Decitabine + Pacritinib | Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations | Completed | USA | 0 |
NCT02756962 | Phase II | Midostaurin Cytarabine | Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance | Recruiting | USA | 0 |
NCT04223596 | Phase II | Brigatinib | Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (CUBIK) | Recruiting | ESP | 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 |
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 |
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 |
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 |
NCT02400281 | Phase Ib/II | Azacitidine Crenolanib Cytarabine + Idarubicin | Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients | Completed | 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 | |
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 |
NCT02723435 | Phase II | Midostaurin | Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant | Withdrawn | 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 |
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 | 8 |
NCT01831726 | Phase II | Dovitinib | Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib | 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 |
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 |
NCT04491084 | Phase Ib/II | CDX-1140 + CDX-301 | FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy (FLT3) | Recruiting | 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 |