Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation Clinical Trial
Official title:
Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study will evaluate safety as well as determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Participants considered an adult according to local regulations at the time of signing informed consent will be randomized in a 1:1 ratio to receive ASP2215 or salvage chemotherapy. Participants will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator will preselect a salvage chemotherapy regimen for each participant; options will include low-dose cytarabine (LoDAC), mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) or fludarabine, high-dose cytarabine and granulocyte colony-stimulating factor (FLAG). The randomization will be stratified by response to first-line therapy and preselected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles. Among the participants, approximately 20 Chinese participants who are randomized into the ASP2215 arm will be allocated to the pharmacokinetic (PK) cohort. Participants in the PK cohort will be requested to be hospitalized from the date of randomization (Day 1) to at least the completion of all the assessments planned on Day 2. All participants in the PK cohort will undergo blood sampling for PK measurement of ASP2215. Participants in PK cohort will be administered the study drug in the same manner and undergo the same efficacy and safety assessments as other participants except for blood sampling for additional PK measurements. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03730012 -
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)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04691648 -
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
|
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| Active, not recruiting |
NCT02752035 -
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
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Phase 3 |