Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917405
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-05-16
Brief Title:
Study Comparing the Efficacy of 2 RIC Regimens Clofarabine vs Fludarabine in Adults With AML Eligible to Allo-SCT
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
FLUCLORIC Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens ClofarabineBusulfan vs FludarabineBusulfan in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2023-11
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:
FLUCLORIC
Brief Summary:
Relapse remains the main cause of death in patients with myeloid malignancies especially after an allotransplant Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia AML as part of the conditioning regimen Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning RIC regimen compared to the FB2A2 for AML patients302 AML patients 151 in each arm in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases 70 vs 55 A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant Clofarabine will be furnished to all centers The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None