Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03409081
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-09-13
First Post:
2018-01-18
Brief Title:
Early Access Program EAP of Gilteritinib ASP2215 in Patients With FMS-like Tyrosine Kinase 3 FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia AML or With 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:
Early Access Program EAP of Gilteritinib ASP2215 in Patients With FMS-like Tyrosine Kinase 3 FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia AML or With FLT3-Mutated AML in Complete Remission CR With Minimal Residual Disease MRD
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-09
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 gilteritinib ASP2215 for patients with FMS-like tyrosine kinase 3 FLT3-mutated relapsed or refractory acute myeloid leukemia AML or with 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 minimal residual disease MRD without access to comparable or alternative therapy
Detailed Description:
This treatment protocol is being conducted while phase 3 gilteritinib ASP2215 studies are ongoing in FLT3-mutated AML patients
Patients will be administered treatment over 28-day cycles Patients will complete visits on cycle 1 days 1 4 8 15 cycle 2 days 1 15 day 1 of cycles 3 through 6 and day 1 of every 2 cycles thereafter until discontinued from the program
An end of treatment visit will be performed within 7 days after last dose of medicinal product gilteritinib ASP2215 or prior to initiation of another anticancer therapy whichever occurs earlier followed by a 30-day follow-up
Patients will be administered treatment over 28-day cycles Patients will complete visits on cycle 1 days 1 4 8 15 cycle 2 days 1 15 day 1 of cycles 3 through 6 and day 1 of every 2 cycles thereafter until discontinued from the program
An end of treatment visit will be performed within 7 days after last dose of medicinal product gilteritinib ASP2215 or prior to initiation of another anticancer therapy whichever occurs earlier followed by a 30-day follow-up
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