Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02298166
Status:
TERMINATED
Last Update Posted:
2021-10-06
First Post:
2014-11-19
Brief Title:
Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Dose-Finding Run-in Phase I Followed by a Phase III Multicenter Randomized Double-Blind Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The manufacturer Arog Pharmaceuticals Inc has terminated the Agreement Concerning the Support of an Investigator Initiated Trial this became valid on 20200309
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main trial is a double-blinded placebo-controlled randomized phase III multi-center trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation as defined in the inclusion exclusion criteria
An initial open label dose-finding run-in phase I of the study will be performed administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone and cytarabine MC in 18 patients according to the experimental arm of the study After completion of this dose-finding run-in phase I toxicity and response data will be provided to the external Data and Safety Monitoring Board DSMB and the Trial Committee by the Coordinating Investigator The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the further conduct of the study with regard to the double-blinded placebo-controlled randomized phase of the study
The double-blinded placebo-controlled randomized portion will start after the completion of the dose-finding run-in phase I and positive opinion of the Trial Committee
Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next chemotherapy if receiving allogeneic HCT crenolanib is held 48 hours prior to conditioning and restarts no sooner than 30 days and not later than day 100 after transplant
Sample size randomized phase 276 patients
Primary objective To evaluate the impact of crenolanib given in combination with salvage chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and ongoing single agent maintenance therapy with crenolanib on event-free EFS and overall survival OS in adult patients with relapsed or refractory AML harboring FLT3 activating mutations
An initial open label dose-finding run-in phase I of the study will be performed administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone and cytarabine MC in 18 patients according to the experimental arm of the study After completion of this dose-finding run-in phase I toxicity and response data will be provided to the external Data and Safety Monitoring Board DSMB and the Trial Committee by the Coordinating Investigator The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the further conduct of the study with regard to the double-blinded placebo-controlled randomized phase of the study
The double-blinded placebo-controlled randomized portion will start after the completion of the dose-finding run-in phase I and positive opinion of the Trial Committee
Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next chemotherapy if receiving allogeneic HCT crenolanib is held 48 hours prior to conditioning and restarts no sooner than 30 days and not later than day 100 after transplant
Sample size randomized phase 276 patients
Primary objective To evaluate the impact of crenolanib given in combination with salvage chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and ongoing single agent maintenance therapy with crenolanib on event-free EFS and overall survival OS in adult patients with relapsed or refractory AML harboring FLT3 activating mutations
Detailed Description:
None
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