Clinical trials: Gilteritinib
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, 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
Acute Myeloid Leukemia
Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
People with acute myeloid leukemia (AML) are usually treated with chemotherapy. When the cancer comes back (relapse) the next treatment is usually a stem cell transplant.
- Trial name
- NCT06734585
- Testing
- Gilteritinib
- Where
- 18 sites in Australia, Brazil and 4 more
- Volunteers
- 114 people
- Sponsor
- Astellas Pharma Singapore Pte. Ltd.
Myeloid Leukemia
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
- Trial name
- NCT06235801
- Testing
- Gilteritinib, Momelotinib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3…
- Trial name
- NCT04293562
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase Erwinia chrysanthemi, Biospecimen Collection
- Where
- 206 sites in United States, Australia and 2 more
- Volunteers
- 1,400 people
- Sponsor
- Children's Oncology Group
Refractory AML, Relapsed Adult AML
A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed (R/R) FLT3 Mutated Acute MyEloid Leukemia (AML) Patients Treated With Gilteritinib in FrANCE
Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to…
- Conditions
- Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation, FLT3-ITD
- Trial name
- ELEGANCE (NCT05193448)
- Where
- 38 sites in France
- Volunteers
- 177 people
- Sponsor
- French Innovative Leukemia Organisation
Acute Myeloid Leukemia
GM-CLAG in Relapsed/Refractory FLT3-mutated AML
The purpose of this study is to evaluate the dose-limiting toxicities (DLT) and define the maximum tolerated dose (MTD) and the recommended phase II study dose of gilteritinib when combined with mitoxantrone, cladribine…
- Trial name
- NCT05330377
- Testing
- Gilteritinib 40 MG Oral Tablet, Cladribine, Cytarabine
- Where
- United States
- Sponsor
- Ayman H Qasrawi
Acute Myeloid Leukemia
GilteRInf 2022 Study (Gilteritinib Related Infections)
The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group.
- Trial name
- GilteRInf (NCT05791890)
- Testing
- Gilteritinib
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- University of Rome Tor Vergata
Advanced Solid Tumors, Acute Myeloid Leukemia
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical…
- Trial name
- NCT02561455
- Testing
- Gilteritinib
- Where
- 7 sites in United States
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
This phase I/II trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia…
- Conditions
- Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04140487
- Testing
- Azacitidine, Gilteritinib, Venetoclax
- Where
- United States
- Volunteers
- 97 people
- Sponsor
- M.D. Anderson Cancer Center
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
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 (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
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies.
- Trial name
- HERKULES-4 (NCT05279859)
- Testing
- ERAS-007, ERAS-601, Gilteritinib
- Where
- 4 sites in United States
- Sponsor
- Erasca, 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
Healthy Volunteer
A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects
The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib…
- Trial name
- NCT03964038
- Testing
- gilteritinib, gilteritinib mini tablet
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- 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
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML).
- Trial name
- NCT02014558
- Testing
- Gilteritinib, Voriconazole, Midazolam
- Where
- 26 sites in United States, Germany and 1 more
- Volunteers
- 265 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia, FLT3-mutated Acute Myeloid Leukemia
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status…
- Trial name
- NCT02310321
- Testing
- Gilteritinib, Idarubicin, Cytarabine
- Where
- 55 sites in Japan, South Korea and 1 more
- Volunteers
- 97 people
- Sponsor
- Astellas Pharma Inc