Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02400281
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2015-03-18
Brief Title:
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Sponsor:
Arog Pharmaceuticals Inc
Organization:
Arog Pharmaceuticals Inc
Study Overview
Official Title:
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
Status:
COMPLETED
Status Verified Date:
2024-06
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 an open label two-arm Phase I-II trial non-randomized Arm 1 crenolanib with standard chemotherapy IdarubicinCytarabine MECMitoxantroneEtoposideCytarabine FLAG-Ida FludarabineCytarabineG-CSFIdarubicin Arm 2 crenolanib with 5-azacitidine
Detailed Description:
For each arm
The phase I with dose-limiting toxicity DLT determination will use 33 design
Phase II total of 52 patients 26 per arm will be treated at established phase I dose
Enrollment to be simultaneous to each arm
The phase I with dose-limiting toxicity DLT determination will use 33 design
Phase II total of 52 patients 26 per arm will be treated at established phase I dose
Enrollment to be simultaneous to each arm
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