Ignite Creation Date:
2024-05-06 @ 9:48 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03070093
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2021-04-20
First Post:
2017-02-28
Brief Title:
Expanded Access Study of Gilteritinib ASP2215 in Patients With FMS-like Tyrosine Kinase 3 FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia AML or FLT3-Mutated AML in Complete Remission CR With Minimal Residual Disease MRD
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multicenter Open-label Treatment Protocol of Gilteritinib ASP2215 in Patients With FMS-like Tyrosine Kinase 3 FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia AML or FLT3-Mutated AML in Complete Remission CR With Minimal Residual Disease MRD
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2021-04
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 provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission CRc complete remission CR complete remission with incomplete hematologic recovery CRi complete remission with incomplete platelet recovery CRp with MRD without access to comparable or alternative therapy
Detailed Description:
The United States Food and Drug Administration FDA the Japanese Ministry of Health Labour and Welfare MHLW and Health Canada have approved ASP2215Gilteritinib XOSPATA for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia AML with a FLT3 mutation
This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in FLT3-mutated AML subjects
Subjects will complete visits on cycle 1 - days 1 4 8 15 cycle 2 - days 1 15 cycles 3 to 6 - day 1 and day 1 of every 2 cycles thereafter ie cycle 8 day 1 cycle 10 day 1 etc until discontinued from the study
Subjects will be provided with study medication until the investigator determines the subject is no longer receiving clinical benefit
An end of treatment visit will be performed within 7 days after last dose of investigational product ASP2215 or prior to initiation of another anticancer therapy whichever occurs earlier followed by a 30-day follow-up Specific to investigational sites in Japan Study population does not include subjects with FLT3-mutated AML in CRc CR CRi CRp with MRD Hence efficacy MRD response rate and duration of response data will not be collected for subjects enrolled in Japan
This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in FLT3-mutated AML subjects
Subjects will complete visits on cycle 1 - days 1 4 8 15 cycle 2 - days 1 15 cycles 3 to 6 - day 1 and day 1 of every 2 cycles thereafter ie cycle 8 day 1 cycle 10 day 1 etc until discontinued from the study
Subjects will be provided with study medication until the investigator determines the subject is no longer receiving clinical benefit
An end of treatment visit will be performed within 7 days after last dose of investigational product ASP2215 or prior to initiation of another anticancer therapy whichever occurs earlier followed by a 30-day follow-up Specific to investigational sites in Japan Study population does not include subjects with FLT3-mutated AML in CRc CR CRi CRp with MRD Hence efficacy MRD response rate and duration of response data will not be collected for subjects enrolled in Japan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None