Clinical trials: FLT3-ITD Mutation
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
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
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 With FLT3/ITD Mutation, Recurrent Acute Myeloid Leukemia
Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
This phase Ib/II trial studies the side effects and best dose of venetoclax in combination with quizartinib and how well they work in treating patients with acute myeloid leukemia that has come back or does not respond to…
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Leukemia
- Trial name
- NCT03735875
- Testing
- Quizartinib, Venetoclax
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- M.D. Anderson 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
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 Biphenotypic Leukemia, Acute Myeloid Leukemia
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte colony-stimulating factor [G-CSF]), cladribine, cytarabine, and mitoxantrone, when given together with sorafenib and to see how well they…
- Conditions
- Acute Biphenotypic Leukemia, Acute Myeloid Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome
- Trial name
- NCT02728050
- Testing
- Cladribine, Cytarabine, Filgrastim
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Washington
Leukemia, Myeloid, Acute
Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (allo-SCT) in FLT3-ITD AML Patients
Recent advances in acute myeloid leukemia (AML) have been characterized by a better understanding of disease biology. As such, FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) have been recognized as conferring a…
- Trial name
- PONALLO (NCT03690115)
- Testing
- Ponatinib 30 MG
- Where
- 14 sites in France
- Volunteers
- 23 people
- Sponsor
- Versailles Hospital
Acute Myeloid Leukemia
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation
- Trial name
- MIDOKIT (NCT01830361)
- Testing
- midostaurin (PKC412)
- Where
- 10 sites in Germany
- Volunteers
- 18 people
- Sponsor
- Technische Universität Dresden
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)
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
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 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
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
AML, Adult
HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
This is a non-randomized prospective open-label single-arm clinical phase I trial investigating dose finding, feasibility and safety of the combined treatment of HDM201 and midostaurin in patients with relapsed/refractory acute…
- Trial name
- HDMM (NCT04496999)
- Testing
- HDM201, Midostaurin
- Where
- Switzerland
- Volunteers
- 2 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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)
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