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Profile Name FLT3 exon 14 ins FLT3 D835H
Gene Variant Detail

FLT3 D835H (gain of function)

FLT3 exon 14 ins (gain of function - predicted)

Relevant Treatment Approaches

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Clinical Trial Phase Therapies Title Recruitment Status
Clinical Trial Phase Therapies Title Recruitment Status
NCT03701308 Phase II Cytarabine + Daunorubicin Cytarabine + Uproleselan Cytarabine + Daunorubicin + Uproleselan Cytarabine Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy Recruiting
NCT02272998 Phase II Ponatinib Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT. Recruiting
NCT02421939 Phase III Cytarabine Cytarabine + Fludarabine + Idarubicin Cytarabine + Etoposide + Mitoxantrone Azacitidine Gilteritinib Filgrastim A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation Active, not recruiting
NCT01657682 Phase II Crenolanib A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations Completed
NCT03900949 Phase I Midostaurin Cytarabine Cytarabine + Gemtuzumab ozogamicin Cytarabine + Daunorubicin + Gemtuzumab ozogamicin Testing the Combination of Standard Induction Therapy With Gemtuzumab Ozogamicin and Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia Recruiting
NCT02283177 Phase II Crenolanib + Cytarabine + Daunorubicin A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations Completed
NCT01892371 Phase Ib/II Azacitidine + Quizartinib Cytarabine + Quizartinib Quizartinib With Azacitidine or Cytarabine in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Active, not recruiting
NCT02752035 Phase II Gilteritinib Azacitidine + Gilteritinib Azacitidine A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy Recruiting
NCT03512197 Phase III Daunorubicin + Midostaurin Cytarabine + Idarubicin + Midostaurin Cytarabine + Idarubicin Daunorubicin A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML) Active, not recruiting
NCT03904069 Phase I Anti-FLT3 CAR-T cells Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML Not yet recruiting
NCT02846376 Phase I Ipilimumab Ipilimumab + Nivolumab Nivolumab Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant (CPIT-002) Active, not recruiting
NCT03674411 Phase II Busulfan + Filgrastim + Fludarabine + Melphalan + MGTA-456 + Mycophenolate mofetil + Tacrolimus Cyclophosphamide + Filgrastim + Fludarabine + MGTA-456 + Mycophenolate mofetil + Tacrolimus Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy Active, not recruiting
NCT02927262 Phase III Gilteritinib A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission Active, not recruiting
NCT03661307 Phase Ib/II Decitabine + Quizartinib + Venetoclax Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Recruiting
NCT03513484 Phase I Azacitidine + Nintedanib Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia Recruiting
NCT03365661 Phase II ALT-803 QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML Withdrawn
NCT02668653 Phase III Cytarabine + Daunorubicin + Idarubicin Cytarabine + Daunorubicin + Idarubicin + Quizartinib Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First) Active, not recruiting
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
NCT04209725 Phase II CPX-351 + Quizartinib A Study of CPX-351 (Vyxeos) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia Recruiting
NCT02997202 Phase III Gilteritinib A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML) Active, not recruiting
NCT03250338 Phase III Cytarabine + Filgrastim + Fludarabine + Idarubicin + Mitoxantrone Crenolanib + Cytarabine + Filgrastim + Fludarabine + Idarubicin + Mitoxantrone Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML Recruiting
NCT03793478 Phase Ib/II Etoposide Cytarabine + Fludarabine + Methotrexate + Prednisolone + Quizartinib Cytarabine + Daunorubicin + Fludarabine + Methotrexate + Prednisolone + Quizartinib Cytarabine + Daunorubicin + Fludarabine + Hydrocortisone + Methotrexate + Quizartinib Cytarabine + Fludarabine + Methotrexate + Prednisolone Quizartinib Safety and Effectiveness of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood Recruiting
NCT04518345 Phase Ib/II Dubermatinib Azacitidine + Dubermatinib TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia Not yet recruiting
NCT02756962 Phase II Midostaurin Cytarabine Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance Recruiting
NCT03552029 Phase I Milademetan Tosylate + Quizartinib Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) Recruiting
NCT03836209 Phase II Cytarabine + Daunorubicin + Gilteritinib Cytarabine + Daunorubicin + Midostaurin Cytarabine Midostaurin Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia Recruiting
NCT02400255 Phase II Crenolanib Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients Recruiting
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
NCT02270463 Phase Ib/II Tagraxofusp-erzs SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission Completed
NCT03709758 Phase I Cytarabine + Daunorubicin + Venetoclax Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naive AML Recruiting
NCT04336982 Phase Ib/II Azacitidine + CC-90009 + Venetoclax CC-90009 + Gilteritinib A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia Recruiting
NCT03735875 Phase Ib/II Quizartinib + Venetoclax Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia Recruiting
NCT04493138 Phase Ib/II Azacitidine + Quizartinib Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations Recruiting
NCT02039726 Phase III Cytarabine + Fludarabine Cytarabine + Etoposide + Mitoxantrone Quizartinib Filgrastim + Idarubicin (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive Active, not recruiting
NCT04240002 Phase Ib/II Cytarabine + Filgrastim + Fludarabine + Gilteritinib A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) Recruiting
NCT03613532 Phase I Busulfan + Fludarabine + Venetoclax Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN Recruiting
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
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
NCT01398462 Phase I CWP232291 Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients Completed
NCT01266083 Phase II WT1 vaccine Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) Completed
NCT02335814 Phase I FLX925 First-in-Human Study of FLX925 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia Terminated
NCT01831726 Phase II Dovitinib Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Completed
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
NCT03701295 Phase Ib/II Azacitidine + Pinometostat Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement Recruiting
NCT02723435 Phase II Midostaurin Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant Withdrawn
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
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
NCT02487459 Phase I BPX-501 Rimiducid Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies Withdrawn
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
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
NCT02532231 Phase II Nivolumab Nivolumab in AML in Remission at High Risk for Relapse Recruiting
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
NCT03194685 Phase Ib/II FF-10101 Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Recruiting
NCT04051996 Phase II Decitabine + Glasdegib GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia Recruiting
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
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
NCT01883362 Phase II Midostaurin Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML Completed
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
NCT03825796 Phase II CPX-351 + Enasidenib Cytarabine + Enasidenib Enasidenib CPX-351 Plus Enasidenib for Relapsed AML Recruiting
NCT02634827 Phase II Decitabine + Midostaurin Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation Terminated
NCT02747537 Phase II Irinotecan + Sorafenib Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan Withdrawn
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
NCT02400281 Phase Ib/II Azacitidine Crenolanib Cytarabine + Idarubicin Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients Completed
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
NCT02270788 Phase I Cytarabine + Leucovorin + Methotrexate Crenolanib + Sorafenib Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies Completed
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
NCT02126553 Phase II Lenalidomide Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission Recruiting
NCT02418000 Phase Ib/II E6201 A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 Mutation Terminated
NCT01338987 Phase II Tacrolimus Busulfan Methotrexate Leuprolide Cyclophosphamide Fludarabine Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation Active, not recruiting
NCT02193152 Phase I Pazopanib Pazopanib in Molecularly Selected Patients With Advanced NSCLC Terminated
NCT00887068 Phase III Azacitidine Randomized Allogeneic Azacitidine Study Completed
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
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 Suspended
NCT02323607 Phase I Cytarabine + Daunorubicin + Pacritinib Decitabine + Pacritinib Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations Completed
NCT04062266 Phase II Azacitidine + Venetoclax Azacitidine and Venetoclax in Treating Patients With High Risk Acute Myeloid Leukemia in Remission Recruiting