Clinical trials: FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia
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.
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 With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation
The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.
- Trial name
- NCT04691648
- Testing
- Gilteritinib Exposure
- Where
- 10 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Astellas Pharma Korea, Inc.
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
CLN-049-001 is a Phase 1/2, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
- Conditions
- Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), TP53-mutated MDS and AML
- Trial name
- NCT05143996
- Testing
- CLN-049
- Where
- 17 sites in United States
- Volunteers
- 275 people
- Sponsor
- Cullinan Therapeutics 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), 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
Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
The purpose of this study was to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3)…
- Trial name
- NCT03379727
- Testing
- Midostaurin, Cytarabine, anthracycline ((daunorubicin or idarubicin): Induction Phase only
- Where
- 86 sites in Bulgaria, Croatia and 13 more
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2.
- Trial name
- NCT00045942
- Testing
- Itraconazole, PKC412
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia, Acute Myeloid Leukemia
Managed Access Programs for PKC412, Midostaurin
The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.
- Conditions
- FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia, Acute Myeloid Leukemia, Aggressive Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT05219266
- Testing
- midostaurin
- Sponsor
- Novartis Pharmaceuticals
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
AML With FLT3 Mutation
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (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 AML who were refractory to or had relapse after first-line AML therapy as shown with…
- Trial name
- NCT03182244
- Testing
- Gilteritinib, Cytarabine, Mitoxantrone
- Where
- 49 sites in China, Malaysia and 3 more
- Volunteers
- 276 people
- Sponsor
- Astellas Pharma Inc
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal.
- Trial name
- NCT02752035
- Testing
- gilteritinib, azacitidine
- Where
- 111 sites in United States, Australia and 11 more
- Volunteers
- 183 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in…
- Trial name
- NCT03409081
- Testing
- gilteritinib
- Where
- 6 sites in Australia, Italy and 1 more
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia With FLT3/ITD Mutation, Allogeneic Hematopoietic Stem Cell Transplantation
The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD AML patients after allo-HSCT in terms of gut microbiome.
- Trial name
- NCT05596981
- Testing
- Sorafenib
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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
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