Clinical trials: FLT3 Gene Mutation
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
Acute Myeloid Leukemia
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation.
- Trial name
- NCT03836209
- Testing
- Gilteritinib, Midostaurin, Daunorubicin
- Where
- 44 sites in United States
- Volunteers
- 181 people
- Sponsor
- PrECOG, LLC.
Acute Myeloid Leukemia, Myelodysplastic Syndrome
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase I/II trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT05010122
- Testing
- Decitabine and Cedazuridine, Gilteritinib, Venetoclax
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- M.D. Anderson Cancer Center
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
AML, Adult, Refractory AML
Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia
Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group.
- Conditions
- AML, Adult, Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation
- Trial name
- OGILAR (NCT06022003)
- Testing
- AzaCITIDine Oral Tablet, Xospata
- Where
- 20 sites in France
- Volunteers
- 33 people
- Sponsor
- French Innovative Leukemia Organisation
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 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
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
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
FLT3-ITD Mutation, AML
Using Sorafenib as a Salvage Treatment for Relapsed or Refractory Acute Myeloid Leukemia Carrying FLT3-ITD
Patients with refractory or relapsed acute myeloid leukemia (AML) after two courses of standard chemotherapy regimens have very limited options.
- Trial name
- NCT03622541
- Testing
- Sorafenib 200mg
- Where
- Hong Kong
- Volunteers
- 46 people
- Sponsor
- The University of Hong Kong
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
Leukemia, Myeloid, Acute
Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia
Acute myeloid leukemia (AML) with FLT3 mutation accounts for 30% of patients and is associated with a poor prognosis. Because of the FLT3 mutation, a tyrosine kinase inhibitor, midostaurin (MIDO), is added to the standard…
- Trial name
- MIDOVEN (NCT07726576)
- Testing
- Venetoclax in association with 3+7 and midostaurin
- Where
- 3 sites in France
- Volunteers
- 41 people
- Sponsor
- University Hospital, Bordeaux
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, in Relapse, Acute Myeloid Leukemia Refractory
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+).
- Trial name
- FRIDA (NCT05546580)
- Testing
- Iadademstat, Gilteritinib Oral Tablet
- Where
- 13 sites in United States
- Volunteers
- 50 people
- Sponsor
- Oryzon Genomics S.A.
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond…
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT06222580
- Testing
- Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Gilteritinib
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Uma Borate
Acute Myeloid Leukemia (AML)
A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)
The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3…
- Trial name
- NCT03512197
- Testing
- Midostaurin, Chemotherapy
- Where
- 133 sites in United States, Argentina and 18 more
- Volunteers
- 511 people
- Sponsor
- Novartis Pharmaceuticals
AML, FLT3-ITD Mutation
Italian Non-Interventional Study of FLT3 Mutated AML Patients
This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations
- Conditions
- AML, FLT3-ITD Mutation, FLT3-TKD Mutation
- Trial name
- FLAM (NCT03547258)
- Testing
- Clinical and Molecular data collection
- Where
- 33 sites in Italy
- Volunteers
- 800 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Acute Myeloid Leukemia, AML With FLT3 Mutation
Gilteritinib-Azacitidine-Venetoclax Combination Therapy in Patients With Relapsed/Refractory Leukemia
The goal of this clinical trial is to learn if gilteritinib-azacitidine-venetoclax combination drug therapy works to treat adults with FLT3-wt acute myeloid leukemia (AML).
- Trial name
- GAVE001 (NCT07755202)
- Testing
- gilteritinib-azacitidine-venetoclax
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Florian Kuchenbauer
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 (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