Clinical trials: FLT3-ITD Mutation
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Acute Myeloid Leukemia
MAC vs RIC for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD ( FLT3 - MAC vs RIC )
This is a multicenter, open-label, 1:1 randomized non-inferiority trial with stratification. The study will enroll patients aged 18-60 years with FLT3-ITD-mutated acute myeloid leukemia (AML) who are in first complete remission…
- Trial name
- FLT3 - M vs R (NCT07904884)
- Testing
- RIC, MAC
- Where
- China
- Volunteers
- 310 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
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
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
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
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
Acute Myeloid Leukemia
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic…
- Trial name
- ACE (NCT00989261)
- Testing
- Compound AC220
- Where
- 85 sites in United States, Canada and 7 more
- Volunteers
- 333 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia
A Phase 1 Study of BMF-500 in Adults With Acute Leukemia
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral FLT3 inhibitor, in adult patients with acute leukemia.
- Trial name
- NCT05918692
- Testing
- BMF-500
- Where
- 14 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biomea Fusion Inc.
Leukemia
Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD…
- Trial name
- NCT02196857
- Testing
- Azacytidine, Sorafenib
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia With FLT3/ITD Mutation
A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)
The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS)…
- Trial name
- NCT05876832
- Testing
- XY0206, Salvage Chemotherapy
- Volunteers
- 312 people
- Sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
Acute Myeloid Leukemia
Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
This phase II MyeloMATCH treatment trial compares the combination of azacitidine, venetoclax and quizartinib to the standard treatment of cytarabine, daunorubicin and quizartinib for the treatment of patients with FLT3-ITD mutant…
- Trial name
- NCT07862517
- Testing
- Azacitidine, Biospecimen Collection, Bone Marrow Aspiration
- Volunteers
- 122 people
- Sponsor
- National Cancer Institute (NCI)
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
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 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
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
Leukemia, Myeloid, Acute
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.
- Trial name
- NCT02984995
- Testing
- Quizartinib
- Where
- 27 sites in Japan
- Volunteers
- 37 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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 Lukemia
Ponatinib for FLT3-ITD Acute Myelogenous Leukemia
This project is part of a joint ALFA and GOELAM strategy aiming to improve the survival of patients with newly diagnosed Acute Myeloid Leukemia (AML) aged 18-70 years.
- Trial name
- PONATINIB-AML (NCT02428543)
- Testing
- Ponatinib and Cytarabine
- Where
- 37 sites in France
- Volunteers
- 49 people
- Sponsor
- Versailles Hospital
Acute Myeloid Leukemia (AML) With, FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)
Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor…
- Trial name
- AMLFLT3 (NCT02624570)
- Testing
- Midostaurin
- Where
- 44 sites in United States
- Sponsor
- Novartis Pharmaceuticals
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, 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