Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03258931
Status:
RECRUITING
Last Update Posted:
2020-05-22
First Post:
2017-08-21
Brief Title:
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
Sponsor:
Arog Pharmaceuticals Inc
Organization:
Arog Pharmaceuticals Inc
Study Overview
Official Title:
Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2020-05
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:
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation About 510 subjects will be randomized in a 11 ratio to receive either crenolanib in addition to standard first line treatment of AML chemotherapy and if eligible transplantation arm A or midostaurin and standard treatment arm B Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation Once the FLT3 mutation status is confirmed and additional eligibility is established subject will be randomized and enter into the treatment phase
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