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 is to determine the clinical benefit of ASP2215 therapy in patients with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival compared to salvage chemotherapy.
This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
|Leukemia, Acute Myeloid (AML)||Drug: ASP2215 Drug: LoDAC (Low Dose Cytarabine) Drug: Azacitidine Drug: MEC (Mitoxantrone, Etoposide, Cytarabine) Drug: FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)||Phase 3|
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A 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|
- Overall Survival (OS) [ Time Frame: up to 56 months ]
- Event-free survival [ Time Frame: up to 56 months ]
- Complete remission [ Time Frame: up to 56 months ]
- Leukemia-free survival [ Time Frame: up to 56 months ]
- Duration of remission [ Time Frame: up to 55 months ]
- Composite complete remission [ Time Frame: up to 55 months ]Complete remission (CR) + Complete remission with incomplete hematologic recovery (Cri) + Complete remission with incomplete platelet recovery (CRp)
- Transplantation rate [ Time Frame: up to 55 months ]Transplantation rate is defined as the percentage of subjects undergoing Hematopoietic stem cell transplant (HSCT) during the study period.
- Brief Fatigue Inventory [ Time Frame: up to 20 months ]The Brief Fatigue Inventory (BFI) is used to assess the severity of fatigue and the impact of fatigue on daily functioning in patients with fatigue due to cancer and cancer treatment. The BFI short form has 9 items and a 24-hour recall. A global fatigue score is computed by averaging the 9 items.
|Actual Study Start Date:||October 20, 2015|
|Estimated Study Completion Date:||July 22, 2019|
|Estimated Primary Completion Date:||June 26, 2018 (Final data collection date for primary outcome measure)|
Administered once daily
Active Comparator: Salvage chemotherapy
Options for salvage chemotherapy are limited to the following: Low- Dose Cytarabine (LoDAC), Azacitidine, MEC Induction Chemotherapy, FLAG-IDA Induction Chemotherapy
Drug: LoDAC (Low Dose Cytarabine)
subcutaneous (SC) or intravenous (IV) injectionDrug: Azacitidine
SC or IV injectionDrug: MEC (Mitoxantrone, Etoposide, Cytarabine)
IV injectionDrug: FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
SC (G-CSF) and IV (Fludarabine, Cytarabine, Idarubicin) injection
Subjects considered an adult according to local regulations at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive ASP2215 or salvage chemotherapy. Subjects will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subject; options will include low-dose cytarabine (LoDAC), azacitidine, mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC), or fludarabine, cytarabine, and granulocyte colony-stimulating factor (G-CSF) with idarubicin (FLAG-IDA). The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Subjects will be administered treatment over continuous 28-day cycles.
After treatment discontinuation, subjects will have an end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety, in which a telephone contact with the subject is sufficient unless any assessment must be repeated for resolution of treatment-related AEs. After that, long term follow-up will be done every 3 months up to 3 years from the 30 day follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02421939
|Contact: Astellas Pharma Global Development||800-888-7704 ext 5473||Astellas.email@example.com|
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|Study Director:||Executive Medical Director||Astellas Pharma Global Development, Inc.|