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BIOMARKER:
FLT3-ITD mutation
i
Other names:
FLT3, Fms Related Tyrosine Kinase 3, Receptor-Type Tyrosine-Protein Kinase FLT3, Stem Cell Tyrosine Kinase 1, Fms-Like Tyrosine Kinase 3, CD135, FLK-2, STK1, Growth Factor Receptor Tyrosine Kinase Type III, Fetal Liver Kinase 2
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Entrez ID:
2322
Related biomarkers:
Expression
Mutation
CNA
Fusion
Others
‹
›
Related tests:
LeukoStrat® CDx FLT3 Mutation Assay (6)
LeukoStrat® CDx FLT3 Mutation Assay (6)
Associations
(90)
News
Trials
Phase
Status
Apply
Phase
Status
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Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) (NCT05554393)
Phase 2
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Recruiting
Phase 2
National Cancer Institute (NCI)
Recruiting
Last update posted :
02/20/2025
Initiation :
09/13/2024
Primary completion :
12/31/2025
Completion :
12/31/2025
TP53 • FLT3 • NPM1 • RUNX1 • ASXL1 • RARA • RUNX1T1 • PML • CEBPA
|
TP53 mutation • FLT3-ITD mutation • NPM1 mutation • RUNX1 mutation • ASXL1 mutation • FLT3-TKD mutation
|
Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • Starasid (cytarabine ocfosfate)
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 (NCT05886049)
Phase 1
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Recruiting
Phase 1
National Cancer Institute (NCI)
Recruiting
Last update posted :
02/20/2025
Initiation :
06/20/2024
Primary completion :
12/31/2027
Completion :
12/31/2027
FLT3 • NPM1 • KMT2A
|
FLT3-ITD mutation • FLT3 mutation • NPM1 mutation • MLL mutation
|
daunorubicin • Revuforj (revumenib) • Starasid (cytarabine ocfosfate)
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults with FLT3-ITD Relapse/refractory (R/R) AML (AGORA-1) (NCT05199051)
Phase 2
Centre Antoine Lacassagne
Centre Antoine Lacassagne
Recruiting
Phase 2
Centre Antoine Lacassagne
Recruiting
Last update posted :
02/19/2025
Initiation :
06/03/2023
Primary completion :
03/15/2027
Completion :
03/15/2027
FLT3 • CD33
|
FLT3-ITD mutation • FLT3-TKD mutation • CD33 positive
|
cytarabine • Xospata (gilteritinib) • Mylotarg (gemtuzumab ozogamicin)
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (NCT05457556)
Phase 3
Children's Oncology Group
Children's Oncology Group
Recruiting
Phase 3
Children's Oncology Group
Recruiting
Last update posted :
02/13/2025
Initiation :
03/15/2023
Primary completion :
12/01/2027
Completion :
12/01/2027
FLT3 • ABL1 • BCR • NPM1 • HLA-DRB1 • CEBPA • HLA-DQB1 • HLA-B • HLA-C
|
FLT3-ITD mutation
|
Rituxan (rituximab) • cyclophosphamide • methotrexate • melphalan • Truxima (rituximab-abbs) • fludarabine IV • thiotepa • busulfan • Mabtas (rituximab biosimilar)
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCI-2021-06095) (NCT05010122)
Phase 1/2
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Recruiting
Phase 1/2
M.D. Anderson Cancer Center
Recruiting
Last update posted :
02/13/2025
Initiation :
07/08/2021
Primary completion :
01/30/2026
Completion :
01/30/2026
FLT3
|
FLT3-ITD mutation • FLT3 mutation
|
Venclexta (venetoclax) • Xospata (gilteritinib) • Inqovi (decitabine/cedazuridine)
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (NCI-2018-01789) (NCT03661307)
Phase 1/2
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Recruiting
Phase 1/2
M.D. Anderson Cancer Center
Recruiting
Last update posted :
02/10/2025
Initiation :
10/31/2018
Primary completion :
01/01/2026
Completion :
01/01/2026
TP53 • FLT3
|
TP53 mutation • FLT3-ITD mutation • FLT3 mutation • TP53 deletion
|
Venclexta (venetoclax) • azacitidine • Vanflyta (quizartinib) • decitabine
Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AAML1031) (NCT01371981)
Phase 3
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Active, not recruiting
Phase 3
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
02/04/2025
Initiation :
06/20/2011
Primary completion :
03/31/2019
Completion :
09/30/2027
FLT3
|
FLT3-ITD mutation
|
sorafenib • cytarabine • bortezomib • etoposide IV • daunorubicin • mitoxantrone • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate)
Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients with Hematologic Malignancies (HTLP-ONCO) (NCT04707300)
Phase 1/2
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Recruiting
Phase 1/2
Assistance Publique - Hôpitaux de Paris
Recruiting
Last update posted :
02/03/2025
Initiation :
02/16/2022
Primary completion :
11/01/2025
Completion :
08/01/2027
HLA-DRB1 • CD34 • CD4 • CD7
|
FLT3-ITD mutation • NPM1 mutation
|
SMART 102
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) (NCT04027309)
Phase 3
Stichting Hemato-Oncologie voor Volwassenen Nederland
Stichting Hemato-Oncologie voor Volwass...
Active, not recruiting
Phase 3
Stichting Hemato-Oncologie voor Volwassenen Ned...
Active, not recruiting
Last update posted :
12/17/2024
Initiation :
12/20/2019
Primary completion :
10/01/2025
Completion :
06/01/2033
FLT3
|
FLT3-ITD mutation • FLT3 mutation • FLT3-TKD mutation
|
Xospata (gilteritinib) • midostaurin
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant (HBO-UBC) (NCT03739502)
Phase 2
University of Rochester
University of Rochester
Recruiting
Phase 2
University of Rochester
Recruiting
Last update posted :
08/19/2024
Initiation :
02/28/2019
Primary completion :
04/01/2025
Completion :
04/01/2026
FLT3 • ABL1 • BCR • NPM1 • CD22 • CD34 • CD79A
|
FLT3-ITD mutation • NPM1 mutation
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML (NCT05024552)
Phase 1
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Resear...
Recruiting
Phase 1
H. Lee Moffitt Cancer Center and Research Insti...
Recruiting
Last update posted :
06/13/2024
Initiation :
08/23/2021
Primary completion :
08/01/2024
Completion :
08/01/2025
FLT3
|
FLT3-ITD mutation • FLT3-TKD mutation
|
Xospata (gilteritinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia. (NCT02310321)
Phase 1/2
Astellas Pharma Inc
Astellas Pharma Inc
Active, not recruiting
Phase 1/2
Astellas Pharma Inc
Active, not recruiting
Last update posted :
06/07/2024
Initiation :
02/26/2015
Primary completion :
08/25/2021
Completion :
07/31/2024
FLT3
|
FLT3-ITD mutation
|
cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride
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