Clinical trials: FLT3 Internal Tandem Duplication Positive
Acute Myeloid Leukemia With FLT3/ITD Mutation, Allogeneic Hematopoietic Stem Cell Transplantation
The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD positive AML patients after allo-HSCT in terms of gut microbiome.
- Trial name
- NCT05596968
- Testing
- Sorafenib
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
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)
The purpose of the phase 1 portion (dose escalation) of the study was to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in…
- Trial name
- NCT04240002
- Testing
- gilteritinib, fludarabine, cytarabine
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
AML
(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication…
- Trial name
- NCT02039726
- Testing
- Quizartinib, Salvage Chemotherapy
- Where
- 131 sites in United States, Australia and 17 more
- Volunteers
- 367 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia (AML), FLT3-ITD Mutation
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation.
- Conditions
- Acute Myeloid Leukemia (AML), FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantation (HCT), Maintenance Therapy
- Trial name
- TROPHY-15 (NCT07463651)
- Testing
- Gilteritinib, Sorafenib
- Where
- 2 sites in China
- Volunteers
- 594 people
- Sponsor
- The First Affiliated Hospital of Soochow University
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
Acute Myeloid Leukemia
Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype
This research is being done because treatment options are very limited and usually unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with disease that has relapsed and/or proven resistant to…
- Trial name
- NCT01534260
- Testing
- sorafenib, vorinostat and bortezomib
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Hamid Sayar
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
Acute Myeloid Leukemia
Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it…
- Trial name
- NCT03793478
- Testing
- Quizartinib, Fludarabine, Cytarabine
- Where
- 27 sites in United States, Belgium and 8 more
- Volunteers
- 65 people
- Sponsor
- Daiichi Sankyo
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 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, Acute Myeloid Leukemia With FLT3/ITD Mutation
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML
The purpose of this study is to reveal the influence of co-existing mutations on the efficacy of sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for patients with FLT3-ITD AML.
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Hematopoietic Stem Cell Transplantation
- Trial name
- NCT04788420
- Testing
- Sorafenib
- Where
- China
- Volunteers
- 456 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Leukemia, Myeloid, Acute
Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive.
- Trial name
- NCT01565668
- Testing
- AC220
- Where
- 24 sites in United States, France and 2 more
- Volunteers
- 76 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- NCT01349049
- Testing
- PLX3397
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations
Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies
This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies.
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214
- Trial name
- NCT01760655
- Testing
- Fludarabine phosphate, Busulfan, Total-Body Irradiation
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Acute Myeloid Leukemia, Leukemia
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer…
- Trial name
- QuANTUM-First (NCT02668653)
- Testing
- Chemotherapy, Quizartinib
- Where
- 244 sites in United States, Argentina and 26 more
- Volunteers
- 539 people
- Sponsor
- Daiichi Sankyo
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
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, FLT3 Internal Tandem Duplication Positive
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation.
- Conditions
- Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia, Fit Patients
- Trial name
- GANCE (NCT07259707)
- Testing
- GVA + HDAC Consolidation & Gilteritinib Maintenance
- Where
- China
- Volunteers
- 25 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities
Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.
- Conditions
- Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities, AML (Adult) With Del (5q), AML (Adult) With Inv (16) (p13; q22)
- Trial name
- NCT01846624
- Testing
- Decitabine, Midostaurin
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- David Iberri
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