Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03250338
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2017-08-11
Brief Title:
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in RR FLT3 Mutated AML
Sponsor:
Arog Pharmaceuticals Inc
Organization:
Arog Pharmaceuticals Inc
Study Overview
Official Title:
Phase III Randomized Double-blind Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects 75 Years of Age With RelapsedRefractory FLT3 Mutated Acute Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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 randomized multi-center double-blind placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy consolidation chemotherapy post bone marrow transplantation and as maintenance in relapsedrefractory AML subjects with FLT3 activating mutation
Detailed Description:
None
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 |
|---|---|---|---|
| 2017-001600-29 | EUDRACT_NUMBER | None | None |