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Spots Global Cancer Trial Database for Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

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Trial Identification

Brief Title: Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

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

Study ID: NCT00354120

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, Firenze, , Italy

Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino, Genova, , Italy

Divisione di Ematologia - Istituto Nazionale dei Tumori, Milano, , Italy

U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena, Milano, , Italy

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -, Modena, , Italy

Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano, Monza, , Italy

Divisione Ematologia con trapianto - Ospedale "V. Cervello", Palermo, , Italy

Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia, Pavia, , Italy

Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara, Pescara, , Italy

Ematologia - Ospedale S. Chiara, Pisa, , Italy

Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli, Reggio Calabria, , Italy

Cattedra di Ematologia - Università La Sapienza, Roma, , Italy

Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli, Roma, , Italy

U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni, Roma, , Italy

Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas, Rozzano (MI), , Italy

Ematologia 2 - ASO San Giovanni Battista, Torino, , Italy

Clinica Ematologica - Policlinico Universitario, Udine, , Italy

Contact Details

Name: Alessandro Rambaldi, MD

Affiliation: Divisione di Ematologia - Ospedali Riuniti di Bergamo

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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