Clinical trials: FLT3-ITD Mutation
AML, Leukaemia (Acute Myeloid)
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose…
- Trial name
- AGORA-1 (NCT05199051)
- Testing
- Gemtuzumab ozogamicine - Cytarabine - Gilteritinib
- Where
- 12 sites in France
- Volunteers
- 19 people
- Sponsor
- Centre Antoine Lacassagne
Acute Myeloid Leukemia
Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 (FLT3)-Internal Tandem Duplication (ITD) AML Trial
In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention.
- Trial name
- SIRA (NCT02867891)
- Volunteers
- 396 people
- Sponsor
- Robert Zeiser
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations
Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
This phase II trial studies how well midostaurin and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia and FLT3 mutations.
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, FLT3 Tyrosine Kinase Domain Point Mutation, Secondary Acute Myeloid Leukemia
- Trial name
- NCT02634827
- Testing
- Decitabine, Laboratory Biomarker Analysis, Midostaurin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mayo Clinic
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT03333486
- Testing
- Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Roswell Park Cancer Institute
Acute Myeloid Leukemia
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)
Participants with AML that have gone into remission and come back (relapsed) or gone into remission with a number of leukemia cells still in their system (refractory) will be recruited for this study.
- Trial name
- NCT03552029
- Testing
- Quizartinib, Milademetan
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia, Hematopoietic Stem Cell Transplantation
Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML
The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).
- Trial name
- NCT02474290
- Testing
- Sorafenib
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Nanfang Hospital, Southern Medical University
FLT3 Gene Mutation Negative, FLT3 Internal Tandem Duplication Positive
Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
This phase I/II trial studies the side effects and best dose of quizartinib when given in combination with azacitidine or cytarabine in treating patients with acute myeloid leukemia or myelodysplastic syndrome that have come back…
- Conditions
- FLT3 Gene Mutation Negative, FLT3 Internal Tandem Duplication Positive, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia
- Trial name
- NCT01892371
- Testing
- Azacitidine, Cytarabine, Quizartinib
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- M.D. Anderson Cancer Center
FLT3-ITD Mutation, FLT3/TKD Mutation
Individual Patient Compassionate Use of Crenolanib
Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical…
- Conditions
- FLT3-ITD Mutation, FLT3/TKD Mutation, PDGFR-Alpha D842V, PDGFRA Gene Amplification
- Trial name
- NCT03620318
- Testing
- Crenolanib besylate
- Where
- Italy
- Sponsor
- Arog Pharmaceuticals, Inc.
Acute Biphenotypic Leukemia, Acute Erythroid Leukemia in Remission
Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies.
- Conditions
- Acute Biphenotypic Leukemia, Acute Erythroid Leukemia in Remission, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission
- Trial name
- NCT01028716
- Testing
- Cyclophosphamide, Filgrastim, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Fred Hutchinson Cancer Center
AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment)
Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD
In this multicenter, upfront randomized phase II trial, all patients receive quizartinib in combination with HAM (high-dose cytarabine, mitoxantrone) during salvage therapy.
- Trial name
- Q-HAM (NCT03989713)
- Testing
- MRD-triggered arm, Prophylactic Arm
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- Prof. Dr. Richard F Schlenk
Acute Myeloid Leukemia With FLT3/ITD Mutation, Allogeneic Hematopoietic Stem Cell Transplantation
The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD AML patients after allo-HSCT in terms of gut microbiome.
- Trial name
- NCT05596981
- Testing
- Sorafenib
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Acute Myeloid Leukemia With FLT3/ITD Mutation
AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
Prospective, multi-center, interventional, randomized, open clinical trial for the treatment of acute myeloid leukemia with FLT3 mutations customized upon the prognostic parameter PBC
- Trial name
- AMELIORATE (NCT04174612)
- Testing
- Cytarabine, Daunorubicin, Midostaurin
- Where
- 20 sites in Italy
- Volunteers
- 172 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Acute Myeloid Leukemia With FLT3/ITD Mutation
A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
This study plans to enroll 45 (Groups A, B, and C) to 75 healthy participants (including the sample size of other potential dose groups). The participants will be divided into three dose groups: 37.5 mg, 75 mg, and 150 mg.
- Trial name
- XY0206-CQT (NCT07162116)
- Testing
- XY0206, Moxifloxacin (400 mg)
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
Acute Myeloid Leukemia, Leukemia Cutis
Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia, Leukemia Cutis, Myeloid Neoplasm, Myeloid Sarcoma
- Trial name
- NCT01371981
- Testing
- Asparaginase, Bortezomib, Cytarabine
- Where
- 220 sites in United States, Australia and 3 more
- Volunteers
- 1,645 people
- Sponsor
- National Cancer Institute (NCI)
Leukemia
Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells.
- Trial name
- NCT00553202
- Testing
- anti-thymocyte globulin, busulfan, cyclophosphamide
- Where
- 52 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Children's Oncology Group
Acute Myeloid Leukemia With FLT3/ITD Mutation
Sorafenib Tosylate Before and After Donor Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia
This pilot clinical trial studies the side effects of sorafenib tosylate before and after donor bone marrow transplantation in treating patients with acute myeloid leukemia.
- Trial name
- NCT01578109
- Testing
- Bone Marrow Transplantation, Sorafenib, Sorafenib Tosylate
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- National Cancer Institute (NCI)
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Acute Promyelocytic Leukemia With PML-RARA
- Trial name
- NCT01253070
- Testing
- Biopsy, Bone Marrow Aspiration, Cytarabine
- Where
- 43 sites in United States
- Volunteers
- 54 people
- Sponsor
- National Cancer Institute (NCI)
AML (Acute Myeloid Leukemia)
FLT3-ITD Targeted Therapy in Fit AML Patients
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction…
- Trial name
- FIT-AML (NCT07425808)
- Testing
- Gilteritinib, Venetoclax, Azacitidine (AZA)
- Volunteers
- 230 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Acute Myeloid Leukemia
FLT3-ITD Gene Mutation and CD135 Expression in Acute Myeloid Leukemia.
1. To evaluate expression levels of CD135 2. To assess the frequency of FLT3 gene mutations (ITD) 3. association between FLT3-ITD mutation and CD135 expression and their correlation with hematological, immunophenotypic,and…
- Trial name
- NCT05383014
- Volunteers
- 82 people
- Sponsor
- Assiut University
Leukemia, Myeloid, Acute
A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia (AML) that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD).
- Trial name
- NCT04209725
- Testing
- CPX-351, Quizartinib
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- SCRI Development Innovations, LLC