Clinical trials: FLT3-ITD Mutation
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy in adult patients with AML or higher- risk Myelodysplastic Syndrome (hrMDS).
- Trial name
- NCT04278768
- Testing
- Emavusertib, Venetoclax
- Where
- 32 sites in United States, Czechia and 6 more
- Volunteers
- 366 people
- Sponsor
- Curis, Inc.
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
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 Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences Inc.
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 (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.
Leukemia
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid…
- Trial name
- QuANTUM-WILD (NCT06578247)
- Testing
- Quizartinib, Chemotherapy
- Where
- 284 sites in United States, Australia and 26 more
- Volunteers
- 700 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, Acute Myeloid (AML)
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared…
- Trial name
- NCT05586074
- Testing
- Clifutinib, LoDAC, Azacitidine
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
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
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
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
- Trial name
- RADIUS (NCT01883362)
- Testing
- Midostaurin, Standard of Care
- Where
- 19 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Leukemia
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute…
- Trial name
- NCT06824168
- Testing
- Quizartinib High Dose, Quizartinib Low Dose
- Where
- 64 sites in United States, Australia and 3 more
- Volunteers
- 130 people
- Sponsor
- Daiichi Sankyo
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
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
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 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
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