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| Profile Name | FLT3 exon 14 ins |
| Gene Variant Detail | |
| Relevant Treatment Approaches | FLT3 Inhibitor |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04655391 | Phase I | Glasdegib Glasdegib + Ivosidenib Bosutinib + Glasdegib Gilteritinib + Glasdegib Decitabine + Glasdegib + Venetoclax Enasidenib + Glasdegib | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation | Withdrawn | USA | 0 |
| 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 | USA | 0 |
| NCT06022003 | Phase II | Azacitidine + Gilteritinib | Study 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 Leukemia (OGILAR) | Recruiting | FRA | 0 |
| NCT04140487 | Phase Ib/II | Azacitidine + Gilteritinib + Venetoclax | Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm | Recruiting | USA | 0 |
| NCT06313437 | Phase I | Cytarabine + Daunorubicin + Midostaurin + Revumenib Cytarabine + Midostaurin + Revumenib | Revumenib in Combination With 7+3 + Midostaurin in AML | Recruiting | USA | 0 |
| NCT06578247 | Phase III | Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Cytarabine + Daunorubicin Cytarabine + Daunorubicin + Quizartinib | Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD) | Recruiting | USA | SWE | ROU | POL | NOR | ITA | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | 8 |
| NCT07059975 | Phase I | Asparaginase Erwinia chrysanthemi + Cytarabine Cytarabine + Idarubicin + Venetoclax Cytarabine + Fludarabine + Idarubicin Cytarabine + Etoposide Cytarabine + Hydrocortisone + Methotrexate | UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML | Recruiting | USA | 0 |
| NCT05554406 | Phase II | Cytarabine + Daunorubicin Azacitidine + Venetoclax CPX-351 Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax | Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) | Recruiting | USA | CAN | 1 |
| NCT03513484 | Phase I | Azacitidine + Nintedanib | Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
| NCT05554393 | Phase II | Cytarabine + Daunorubicin Cytarabine + Daunorubicin + Venetoclax Azacitidine + Venetoclax | Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) | Recruiting | USA | CAN | 1 |
| NCT05010122 | Phase Ib/II | Decitabine and Cedazuridine + Gilteritinib + Venetoclax | ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
| NCT07032727 | Phase II | Olutasidenib + Ruxolitinib Gilteritinib + Olutasidenib + Venetoclax Gilteritinib + Olutasidenib Cladribine + Cytarabine + Olutasidenib + Venetoclax Cladribine + Cytarabine + Olutasidenib | Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations | Recruiting | USA | 0 |
| NCT04385290 | Phase Ib/II | Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Midostaurin Cytarabine + Daunorubicin + Gemtuzumab ozogamicin | Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC) (MOSAIC) | Recruiting | DEU | 0 |
| NCT05766514 | Phase II | Cladribine + Cytarabine + Decitabine Decitabine + Venetoclax Azacitidine + Venetoclax | Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction | Withdrawn | USA | 0 |
| 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 | Completed | USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 3 |
| 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 | Completed | USA | POL | NLD | ITA | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUS | 5 |
| 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 | Terminated | USA | 0 |
| NCT04518345 | Phase Ib/II | Dubermatinib Azacitidine + Dubermatinib | TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia | Completed | USA | 0 |
| NCT05697510 | Phase I | Siltuximab | Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM (SILTUXILAM) | Unknown status | FRA | 0 |
| NCT04293562 | Phase III | Cytarabine + Daunorubicin + Hydrocortisone + Methotrexate Cytarabine + Etoposide + Hydrocortisone + Methotrexate Cytarabine + Hydrocortisone + Methotrexate + Mitoxantrone Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Gilteritinib + Hydrocortisone + Methotrexate Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Hydrocortisone + Methotrexate Gilteritinib Asparaginase Erwinia chrysanthemi + Cytarabine Cytarabine + Daunorubicin + Gilteritinib + Hydrocortisone + Methotrexate Cytarabine + Etoposide + Gilteritinib + Hydrocortisone + Methotrexate Cytarabine + Gilteritinib + Hydrocortisone + Methotrexate + Mitoxantrone Asparaginase Erwinia chrysanthemi + Cytarabine + Gilteritinib | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | Recruiting | USA | CAN | AUS | 1 |
| NCT05546580 | Phase I | Gilteritinib + ORY-1001 | Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+) (FRIDA) | Recruiting | USA | 0 |
| 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) | Completed | USA | ROU | POL | ITA | ISR | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUS | ARG | 10 |
| NCT04027309 | Phase III | Midostaurin Gilteritinib | A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML) | Active, not recruiting | SWE | NOR | NLD | LTU | IRL | FRA | FIN | ESP | DEU | CHE | BEL | AUT | AUS | 0 |
| 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 | USA | 0 |
| NCT06366789 | Phase I | Lomonitinib | Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia | Recruiting | AUS | 0 |
| NCT03552029 | Phase I | Milademetan + Quizartinib | Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) | Terminated | USA | 0 |
| NCT03735875 | Phase Ib/II | Quizartinib + Venetoclax | Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia | Terminated | USA | 0 |
| NCT05520567 | Phase Ib/II | Azacitidine + Gilteritinib + Venetoclax | A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia | Recruiting | USA | 0 |
| NCT05183035 | Phase III | Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin + Venetoclax Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin | Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | Recruiting | USA | SWE | NZL | NOR | NLD | ITA | ISR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 2 |
| NCT06222580 | Phase I | Gilteritinib + Revumenib | SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation | Recruiting | USA | 0 |
| NCT06504459 | Phase II | Cladribine + Cytarabine + Venetoclax Azacitidine + Venetoclax | Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML | Recruiting | USA | 0 |
| NCT04168502 | Phase III | Gemtuzumab ozogamicin | Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML | Recruiting | ITA | 0 |
| NCT02400255 | Phase II | Crenolanib | Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients | Completed | USA | 0 |
| NCT06782542 | Phase II | Azacitidine + Olutasidenib + Venetoclax | Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy (OLUVENAZA) | Recruiting | USA | 0 |
| 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 Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood | Active, not recruiting | USA | SWE | NLD | ITA | ISR | FRA | ESP | DNK | CAN | BEL | 0 |
| NCT03690115 | Phase II | Ponatinib | Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (Allo-SCT) in FLT3-ITD AML Patients (PONALLO) | Completed | FRA | 0 |
| NCT02756962 | Phase II | Midostaurin Cytarabine | Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance | Active, not recruiting | USA | 0 |
| 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) | Completed | USA | POL | NZL | ITA | GRC | GBR | FRA | ESP | DNK | DEU | CAN | BEL | AUS | 3 |
| NCT06317649 | Phase II | Azacitidine + Gilteritinib + Venetoclax Azacitidine + Venetoclax | Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) | Recruiting | USA | 1 |
| 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 | Unknown status | USA | ITA | FRA | ESP | DEU | CAN | 0 |
| NCT06824168 | Phase II | Quizartinib | Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission | Recruiting | USA | BRA | AUS | 2 |
| NCT03365661 | Phase II | Nogapendekin alfa inbakicept | QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML | Withdrawn | USA | 0 |
| NCT04107727 | Phase II | Cytarabine Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Quizartinib Cytarabine + Quizartinib | Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) | Completed | ESP | 0 |
| NCT04872478 | Phase I | MRX-2843 | Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults with Relapsed/Refractory AML, ALL, or MPAL | Recruiting | USA | 0 |
| NCT05330377 | Phase I | Cladribine + Cytarabine + Filgrastim + Gilteritinib + Mitoxantrone | GM-CLAG in Relapsed/Refractory FLT3-mutated AML | Withdrawn | USA | 0 |
| NCT02270463 | Phase Ib/II | Tagraxofusp-erzs | SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission | Terminated | USA | 0 |
| NCT03922100 | Phase Ib/II | NMS-P088 | Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML | Terminated | ITA | FRA | ESP | 0 |
| NCT06152809 | Phase I | Aldesleukin + CIML-NK cells + Venetoclax | CIML NK Cells With Venetoclax for AML | Recruiting | USA | 0 |
| NCT05024552 | Phase I | CPX-351 + Gilteritinib | Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | Recruiting | USA | 0 |
| 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 | Completed | USA | SWE | ROU | POL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | 5 |
| NCT06235801 | Phase Ib/II | Gilteritinib + Momelotinib | A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia | Recruiting | USA | 0 |
| NCT05599360 | Phase II | CPX-351 + Gemtuzumab ozogamicin | Vyxeos for Induction of Low- or Intermediate-risk. | Active, not recruiting | ISR | 0 |
| NCT05886049 | Phase I | Cytarabine + Daunorubicin + Revumenib | Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene | Recruiting | USA | 0 |
| 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 | USA | 0 |
| 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 | Terminated | USA | GBR | FRA | CAN | BEL | 0 |
| NCT07177079 | Phase I | Decitabine + Venetoclax Azacitidine + Venetoclax Azacitidine + Venetoclax + Vitamin C Decitabine + Venetoclax + Vitamin C | High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML) | Not yet recruiting | USA | 0 |
| NCT03836209 | Phase II | Cytarabine + Daunorubicin + Gilteritinib Cytarabine + Daunorubicin + Midostaurin Cytarabine Midostaurin | Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
| 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) | Terminated | USA | ITA | GBR | ESP | DEU | 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 |
| NCT07228273 | Phase II | Cytarabine + Daunorubicin Cytarabine + Fludarabine + Idarubicin + Venetoclax | Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia | Not yet recruiting | USA | 0 |
| NCT05756777 | Phase I | Gilteritinib + Ivosidenib Enasidenib + Gilteritinib | A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) | Recruiting | USA | 0 |
| NCT04669067 | Phase Ib/II | KRT-232 + TL-895 | TL-895 and KRT-232 Study in Acute Myeloid Leukemia | Unknown status | USA | ITA | FRA | ESP | DEU | AUT | AUS | 1 |
| NCT05558124 | Phase I | CPX-351 + Gemtuzumab ozogamicin | CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML | Recruiting | USA | 0 |
| 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 | USA | 0 |
| NCT01892371 | Phase Ib/II | Azacitidine + Quizartinib Cytarabine + Quizartinib | Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome | Completed | USA | 0 |
| NCT04817241 | Phase Ib/II | Cytarabine + Daunorubicin Decitabine and Cedazuridine + Venetoclax | Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients | Active, not recruiting | USA | 0 |
| NCT03709758 | Phase I | Cytarabine + Daunorubicin + Venetoclax | Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naive AML | Recruiting | USA | 0 |