Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02421939
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2015-04-16
Brief Title:
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia AML With FMS-like Tyrosine Kinase FLT3 Mutation
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03070093
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants 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 CRCRh in these participants
This study will also determine the overall efficacy in event-free survival EFS and complete remission CR rate of ASP2215 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
Detailed Description:
Participants considered an adult according to local regulations at the time of signing informed consent may participate in this study Participants will be randomized in a 21 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 a salvage chemotherapy regimen will be pre-selected for each participant 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 Participants will be administered treatment over continuous 28-day cycles
After treatment discontinuation participants will have a pre-hematopoietic stem cell transplant HSCTend-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 participant 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 participants end-of-treatment visit
After treatment discontinuation participants will have a pre-hematopoietic stem cell transplant HSCTend-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 participant 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 participants end-of-treatment visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-000140-42 | EUDRACT_NUMBER | None | None |