Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03182244
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2017-06-08
Brief Title:
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia AML With FLT3 Mutation
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
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 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
Detailed Description:
Participants considered an adult according to local regulations at the time of signing informed consent will be randomized in a 11 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
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
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20170326 | REGISTRY | Chinadrugtrialsorgcn | None |