Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02997202
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2016-12-01
Brief Title:
A Trial of the FMS-like Tyrosine Kinase 3 FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3Internal Tandem Duplication ITD Acute Myeloid Leukemia AML
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3ITD AML
Status:
COMPLETED
Status Verified Date:
2024-08
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 was to compare relapse-free survival between participants with FLT3ITD AML in first morphologic complete remission CR1 who underwent hematopoietic stem cell transplant HCT and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period
Detailed Description:
Participants with FLT3ITD AML in first morphologic complete remission CR1 undergone allogeneic hematopoietic stem cell transplant HCT were randomized to receive gilteritinib or placebo 30 to 90 days after HCT for a two year period Participants wiere stratified according to 1 conditioning regimen intensity myeloablative vs reduced intensitynon-myeloablative 2 time from first day of hematopoietic cell infusion to randomization 30-60 days vs 61-90 days and 3 presence vs absence of or unknown minimal residual disease MRD from the most recent pre-registration bone marrow BM aspirate
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 |
|---|---|---|---|
| 2016-001061-83 | EUDRACT_NUMBER | None | None |
| BMT CTN 1506 | OTHER | Blood and Marrow Transplant Clinical Trials Network | None |