Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
3 years
Yes
Alessandro Rambaldi, MD
Study Chair
Divisione di Ematologia - Ospedali Riuniti di Bergamo
Italy: Ministry of Health
EudraCT:2005-000805-68
NCT00354120
March 2005
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