Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354120
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2006-07-19
Brief Title:
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Organization:
Gruppo Italiano Trapianto di Midollo Osseo
Study Overview
Official Title:
Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors
Status:
COMPLETED
Status Verified Date:
2023-03
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:
GLOBAL
Brief Summary:
The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors
Detailed Description:
The reduction of intensity of conditioning is currently indicated for patients who cannot undergo standard myelo-ablation due to their age comorbidities or type of pathology Furthermore the rationale to use RIC regimens is based on the observation that the infusion of alloreactive donor lymphocytes may yield to a graft versus tumour effect However in this kind of regimens the morbidity and TRM due to GvHD are still a concern and in vivo T-depletion is a necessary treatment Both monoclonal Alemtuzumab and polyclonal T-depletion protocols carry risks and benefits Benefits being a better prophylaxis for GvHD and risks being an higher incidence of post-transplantation infections and relapse At the moment it is not clear which type of regimen monoclonal or polyclonal is better for the treatment
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