Clinical trials: FLT3-ITD Mutation
Acute Myeloid Leukemia
Protocol in Acute Myeloid Leukemia With FLT3-ITD
This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.
- Trial name
- NCT01477606
- Testing
- Midostaurin, Cytarabine, Daunorubicin
- Where
- 55 sites in Austria, Germany
- Volunteers
- 451 people
- Sponsor
- University of Ulm
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
AML, FLT3-ITD Mutation
Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD
The study aims to test if combination of sorafenib and omacetaxine mepesuccinate (OM, also known as homoharringtonine) results in durable composite complete remission (CRc) in patients with newly diagnosed or relapsed/refractory…
- Trial name
- NCT03170895
- Testing
- Sorafenib, Omacetaxine Mepesuccinate Injection
- Where
- Hong Kong
- Volunteers
- 5 people
- Sponsor
- The University of Hong Kong
FLT3-ITD Mutation, Acute Myeloid Leukemia
Combination of BTK Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant AML
Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML. BTK is reported to be a therapeutic target in this subtype leukemia.
- Conditions
- FLT3-ITD Mutation, Acute Myeloid Leukemia, Brutons Tyrosine Kinase
- Trial name
- NCT03642236
- Testing
- Ibrutinib
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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 With Gene Mutations, Adult Acute Myeloid Leukemia in Remission
Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant
This phase 2 trial studies the side effects and how well midostaurin works in treating older patients with acute myeloid leukemia with change in genetic material post-hematopoietic cell transplantation.
- Trial name
- NCT02723435
- Testing
- Midostaurin
- Sponsor
- Stanford University
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
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)
The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to…
- Trial name
- NCT02997202
- Testing
- gilteritinib
- Where
- 118 sites in United States, Australia and 14 more
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Acute Myeloid Leukemia With FLT3/ITD Mutation
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy.
- Trial name
- NCT05024552
- Testing
- Gilteritinib, Vyxeos
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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 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, FLT3-ITD Mutation
Sorafenib to Treat FLT3-ITD AML
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or…
- Trial name
- NCT02156297
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Acute Myeloid Leukemia
Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia.
- Trial name
- NCT01398501
- Testing
- Sorafenib
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Massachusetts General Hospital
Acute Myeloid Leukemia With Gene Mutations
Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib
An expanded access program (EAP): Allows doctors to give medicine to patients, Before it is approved by health authorities. This EAP is for: Quizartinib Patients with FLT3-ITD mutated AML, AML that has come back, or Is resistant…
- Trial name
- NCT03746912
- Testing
- Quizartinib Dihydrochloride
- Sponsor
- Daiichi Sankyo
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 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
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
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, 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)