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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Alentuzumab
Globulina antilinfocitaria
Overall Survival
Time frame: 3 years
Event Free Survival and Disease Free Survival
Time frame: 3 years
Safety:
Time frame: 3 years
Major infective complications (CMV and EBV related PTLD)
Time frame: 3 years
Acute and chronic GvHD
Time frame: 3 years
Haematological and immunologic reconstitution
Time frame: 3 years
Incidence of CMV and EBV reactivation
Time frame: 3 years
Other infective complications
Time frame: 3 years
Other toxicities
Time frame: 3 years
Need for DLI
Time frame: 3 years
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Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"
Alessandria, Italy
Clinica di Ematologia - Ospedali Riuniti di Ancona
Ancona, Italy
Divisione di Ematologia - Ospedali Riuniti Bergamo
Bergamo, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Cattedra di Ematologia - Azienda Ospedaliera di Careggi
Florence, Italy
Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino
Genova, Italy
Divisione di Ematologia - Istituto Nazionale dei Tumori
Milan, Italy
U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena
Milan, Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
Modena, Italy
...and 12 more locations