Clinical Trials Directory

Trials / Completed

CompletedNCT00354120

Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

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
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
121 (actual)
Sponsor
Gruppo Italiano Trapianto di Midollo Osseo · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAlentuzumabAlentuzumab
DRUGGlobulina antilinfocitariaGlobulina antilinfocitaria

Timeline

Start date
2005-03-01
Primary completion
2011-08-01
Completion
2011-08-01
First posted
2006-07-20
Last updated
2023-03-10

Locations

22 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT00354120. Inclusion in this directory is not an endorsement.