A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
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|ClinicalTrials.gov Identifier: NCT02421939|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : November 14, 2018
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 (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these patients.
This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Acute Myeloid (AML)||Drug: gilteritinib 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|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
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 a pre-hematopoietic stem cell transplant (HSCT)/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 adverse events (AEs). After that, long term follow-up will be done every 3 months up to 3 years from the subject's end-of-treatment visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 20, 2015|
|Actual Primary Completion Date :||September 17, 2018|
|Estimated Study Completion Date :||December 2020|
Administered once daily
Other Name: ASP2215
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) injection
SC or IV injection
Drug: MEC (Mitoxantrone, Etoposide, Cytarabine)
Drug: FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
SC (G-CSF) and IV (Fludarabine, Cytarabine, Idarubicin) injection
- Overall Survival (OS) [ Time Frame: up to 30 months ]
- Complete Remission and Complete Remission with partial hematological recovery (CR/CRh) rate [ Time Frame: up to 23 months ]
- Event-free survival [ Time Frame: up to 49 months ]
- Complete remission rate [ Time Frame: up to 36 months ]
- Leukemia-free survival [ Time Frame: up to 49 months ]
- Duration of remission [ Time Frame: up to 36 months ]
- Composite complete remission rate [ Time Frame: up to 36 months ]Complete remission (CR) + Complete remission with incomplete hematologic recovery (Cri) + Complete remission with incomplete platelet recovery (CRp)
- Transplantation rate [ Time Frame: up to 49 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 36 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.
- Complete remission with partial hematological recovery (CRh) rate [ Time Frame: up to 36 months ]
- Transfusion conversion rate [ Time Frame: up to 36 months ]
- Transfusion maintenance rate [ Time Frame: up to 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421939
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|Study Director:||Executive Medical Director||Astellas Pharma Global Development, Inc.|