Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02400255
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2015-03-18
Brief Title:
Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
Sponsor:
Arog Pharmaceuticals Inc
Organization:
Arog Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Study of Crenolanib Besylate Maintenance Following Allogeneic Stem Cell Transplantation in Patients With FLT3-positive Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2023-12
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:
This is a single-arm Phase II study of crenolanib as maintenance in AML patients with FLT3 mutations who have achieved complete remission CR after allogeneic stem cell transplantation Oral crenolanib will be administered daily post-transplant for up to two years
Detailed Description:
There are two patient subgroups 1 those who were in complete remission CR at the time of transplant and 2 those who were not in complete remission NCR at the time of transplant Start of crenolanib therapy at 100 mg TID is intended at the earliest time no sooner than 42 days but no later than 90 days after allogeneic stem cell transplantation Patients may take crenolanib continuously for up to 728 days or until one of the criteria for study discontinuation is fulfilled
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