Clinical trials: AML With FLT3 Mutation
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
Leukemia, Acute Myeloid (AML)
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line…
- Trial name
- NCT02421939
- Testing
- gilteritinib, LoDAC (Low Dose Cytarabine), Azacitidine
- Where
- 126 sites in United States, Belgium and 12 more
- Volunteers
- 371 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and…
- Trial name
- NCT03730012
- Testing
- gilteritinib, atezolizumab
- Where
- 12 sites in United States
- Volunteers
- 11 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).
- Trial name
- NCT00079482
- Testing
- CEP-701, high-dose cytarabine, Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
- Where
- 81 sites in United States, Australia and 11 more
- Volunteers
- 224 people
- Sponsor
- Cephalon
Acute Myeloid Leukemia
Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3…
- Trial name
- NCT04982354
- Testing
- CPX-351, Midostaurin, Busulfan
- Where
- United States
- Sponsor
- Guenther Koehne
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, Myelodysplastic Syndrome With Excess Blasts-2
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML).
- Trial name
- HOVON 156 AML (NCT04027309)
- Testing
- Gilteritinib, Midostaurin
- Where
- 193 sites in Australia, Austria and 11 more
- Volunteers
- 777 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
AML - Acute Myeloid Leukemia
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy
- Trial name
- SEQUENCE (NCT06696183)
- Testing
- Gilteritinib (GILT), Venetoclax (VEN), Azacitidine (AZA)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Technische Universität Dresden
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 (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1)…
- Trial name
- NCT02927262
- Testing
- Gilteritinib
- Where
- 73 sites in United States, Brazil and 19 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation…
- Trial name
- NCT03250338
- Testing
- Crenolanib, Cytarabine, Mitoxantrone
- Where
- 62 sites in United States, Canada and 4 more
- Volunteers
- 106 people
- Sponsor
- Arog Pharmaceuticals, Inc.
Leukemia, Myeloid, Acute
HDM201 Added to CT in R/R or Newly Diagnosed AML
This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML.
- Trial name
- NCT03760445
- Testing
- HDM201, cytarabine, anthracycline
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement
A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute…
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Secondary Acute Myeloid Leukemia
- Trial name
- NCT05886049
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- 23 sites in United States
- Volunteers
- 38 people
- Sponsor
- National Cancer Institute (NCI)
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission…
- Trial name
- NCT03070093
- Testing
- gilteritinib
- Where
- 39 sites in United States, Canada and 1 more
- Sponsor
- Astellas Pharma Global Development, 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
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.
Acute Myeloid Leukemia (AML)
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations.
- Trial name
- NCT05756777
- Testing
- Gilteritinib, Ivosidenib, Enasidenib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering 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
Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years
In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.
- Trial name
- NCT00783653
- Testing
- Sunitinib
- Where
- 5 sites in Germany
- Volunteers
- 22 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf