Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Alentuzumab |
|
| 2 | Active Comparator | Globulina antilinfocitaria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alentuzumab | Drug | Alentuzumab |
| |
| Globulina antilinfocitaria |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years | |
| Event Free Survival and Disease Free Survival | 3 years | |
| Safety: | 3 years | |
| Major infective complications (CMV and EBV related PTLD) | 3 years | |
| Acute and chronic GvHD | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Haematological and immunologic reconstitution | 3 years | |
| Incidence of CMV and EBV reactivation | 3 years | |
| Other infective complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Rambaldi, MD | Divisione di Ematologia - Ospedali Riuniti di Bergamo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy | ||
Not provided
| Label | URL |
|---|---|
| GLOBAL Official Web Site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Globulina antilinfocitaria |
|
| 3 years |
| Other toxicities | 3 years |
| Need for DLI | 3 years |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided