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Gene | FLT3 |
Variant | exon 14 ins |
Impact List | indel |
Protein Effect | gain of function - predicted |
Gene Variant Descriptions | FLT3 exon 14 ins refers to a series of internal tandem duplications (ITD) typically occurring in exon 14 and within the juxtamembrane domain of the Flt3 protein (PMID: 12970773). Exon 14 ins mutations often result in constitutive activation of Flt3 (PMID: 12970773) and therefore, is predicted to lead to a gain of Flt3 protein function. |
Associated Drug Resistance | |
Category Variants Paths |
FLT3 mutant FLT3 act mut FLT3 exon 14 ins FLT3 mutant FLT3 exon14 FLT3 exon 14 ins |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
NCT06366789 | Phase I | ZE46-0134 | 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 | Not yet recruiting | AUS | 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 | 1 |
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 |
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 |
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 | Active, not recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 3 |
NCT05599360 | Phase II | CPX-351 + Gemtuzumab ozogamicin | Vyxeos for Induction of Low- or Intermediate-risk. | Recruiting | ISR | 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 |
NCT04518345 | Phase Ib/II | Dubermatinib Azacitidine + Dubermatinib | TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia | Completed | USA | 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 |
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 |
NCT02400255 | Phase II | Crenolanib | Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients | Completed | USA | 0 |
NCT03552029 | Phase I | Milademetan + Quizartinib | Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) | Terminated | 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) | Not yet recruiting | USA | SWE | ROU | POL | NOR | ITA | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | 8 |
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 | CZE | CHE | CAN | BEL | AUT | AUS | 1 |
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 |
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 |
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 |
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 |
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 |
NCT03735875 | Phase Ib/II | Quizartinib + Venetoclax | Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia | Terminated | USA | 0 |
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 |
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) | Unknown status | ESP | 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 |
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 |
NCT03922100 | Phase Ib/II | NMS-P088 | Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML | Terminated | ITA | FRA | ESP | 0 |
NCT04669067 | Phase Ib/II | KRT-232 + TL-895 | TL-895 and KRT-232 Study in Acute Myeloid Leukemia | Active, not recruiting | USA | ITA | FRA | ESP | DEU | AUT | AUS | 1 |
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 |
NCT06152809 | Phase I | Aldesleukin + CIML-NK cells + Venetoclax | CIML NK Cells With Venetoclax for AML | 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 |
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 |
NCT05558124 | Phase I | CPX-351 + Gemtuzumab ozogamicin | CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML | Recruiting | USA | 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 |
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 |
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 |
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 |
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 |
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 |
NCT05330377 | Phase I | Cladribine + Cytarabine + Filgrastim + Gilteritinib + Mitoxantrone | GM-CLAG in Relapsed/Refractory FLT3-mutated AML | Withdrawn | USA | 0 |
NCT06313437 | Phase I | Cytarabine + Daunorubicin + Midostaurin + Revumenib Cytarabine + Midostaurin + Revumenib | Revumenib in Combination With 7+3 + Midostaurin in AML | Not yet 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) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | 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) | Recruiting | FRA | 0 |
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 |
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 |
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 |
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 |
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 |
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) | Active, not recruiting | FRA | 0 |
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 | LUX | LTU | IRL | FRA | FIN | ESP | DEU | CHE | BEL | AUT | AUS | 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 |
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 | Not yet recruiting | USA | 0 |
NCT05024552 | Phase I | CPX-351 + Gilteritinib | Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | 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 |
NCT04168502 | Phase III | Gemtuzumab ozogamicin + Glasdegib Gemtuzumab ozogamicin | Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML | Recruiting | ITA | 0 |
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 |
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 |
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 |
NCT06366789 | Phase I | ZE46-0134 | 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 | Not yet recruiting | AUS | 0 |