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Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III, Phase II | Treatment | Active | 18 to 65 | EudraCT:2005-000805-68 NCT00354120 |
Trial Description
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. Further Study Information 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. Eligibility Criteria Inclusion Criteria: - Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual)
- Group 2: patients <= 65 yo suffering from lympho-proliferative diseases according the REAL classification:
- High-doses chemotherapy relapsed CLL (B and T)
- Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy
- Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy
- Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy
- Advanced (stage ≥ III A) or relapsed T lymphomas
- Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens
- Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy
- Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells.
Exclusion Criteria: - Performance status < 70% (Karnofsky)
- Left ventricular cardiac ejection fraction < 40% or receiving treatment for heart failure
- DLCO pulmonary < 40% or receiving continuous oxygen therapy
- Neuropathy (previous or at present)
- Patients with arterial hypertension not controlled with multi-pharmacological treatments
- B-CLL with clear evidence of transformation into Richter syndrome
- Mycosis fungoides with clear evidence of transformation into blasts
- Hodgkin's disease refractory to chemotherapy
- Absence of informed consent
- Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment
Trial Contact Information
Trial Lead Organizations/Sponsors Gruppo Italiano Trapianto di Midollo Osseo Alessandro Rambaldi, MD | ![](https://webarchive.library.unt.edu/eot2008/20090510095403im_/http://www.cancer.gov/images/spacer.gif) | Study Chair |
Trial Sites
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Italy |
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Alessandria |
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| | | | | | | Ospedale SS. Biagio e Arrigo |
| | Alessandro Levis | Principal Investigator |
| | Bernardino Allione, MD | Sub-Investigator |
| | Flavia Salvi, MD | Sub-Investigator |
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Ancona |
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| | Ospedale Torrette University Ancona |
| | Pietro Leoni | Principal Investigator |
| | Mauro Montanari, MD | Sub-Investigator |
| | Rossana Re, MD | Sub-Investigator |
| | Guido Gini, MD | Sub-Investigator |
| | Silvia Trappolini, MD | Sub-Investigator |
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Bergamo |
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| | Ospedali Riuniti di Bergamo |
| | Alessandro Rambaldi | Principal Investigator |
| | Caterina Micò, MD | Sub-Investigator |
| | Anna Barbui, MD | Sub-Investigator |
| | Federica Delaini, BSc | Sub-Investigator |
| | Elena Oldani, BSc | Sub-Investigator |
| | Alessandra Carobbio, Stat | Sub-Investigator |
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Cuneo |
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| | Ospedale Santa Croce |
| | Andrea Gallamini | Principal Investigator |
| | Nicola Mordini, MD | Sub-Investigator |
| | Daniele Mattei, MD | Sub-Investigator |
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Firenze |
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| | Azienda Ospedaliero Careggi |
| | Alberto Bosi, MD | Principal Investigator |
| | Letizia Lombardini, MD | Sub-Investigator |
| | Stefano Guidi, MD | Sub-Investigator |
| | Chiara Nozzoli, MD | Sub-Investigator |
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Milano |
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| | Fondazione Istituto Nazionale dei Tumori |
| | Paolo Corradini | Principal Investigator |
| | Vittorio Montefusco, MD | Sub-Investigator |
| | Raffaella Milani, MD | Sub-Investigator |
| | Francesco Zallio, MD | Sub-Investigator |
| | Anna Dodero, MD | Sub-Investigator |
| | Ospedale Maggiore Policlinico |
| | Davide Soligo, MD | Principal Investigator |
| | Elena Tagliaferri, MD | Sub-Investigator |
| | Federica Grifoni, MD | Sub-Investigator |
| | Claudia Vener, MD | Sub-Investigator |
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Pavia |
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| | Fondazione I.R.C.C.S. Policlinico San Matteo |
| | Emilio Paolo Alessandrino, MD | Principal Investigator |
| | Daniela Caldera, MD | Sub-Investigator |
| | Anna Colombo, MD | Sub-Investigator |
| | Paolo Bernasconi, MD | Sub-Investigator |
| | Margherita Maffioli, MD | Sub-Investigator |
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Pescara |
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| | Ospedale Civile Pescara |
| | Paolo Di Bartolomeo, MD | Principal Investigator |
| | Stella Santarone, MD | Sub-Investigator |
| | Gabriele Papalinetti, MD | Sub-Investigator |
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Pisa |
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| | Ospedale Santa Chiara Pisa |
| | Mario Petrini, MD | Principal Investigator |
| | Edoardo Benedetti, MD | Sub-Investigator |
| | Federico Papineschi, MD | Sub-Investigator |
| | Francesco Caracciolo, MD | Sub-Investigator |
| | Rossella Riccioni, MD | Sub-Investigator |
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Reggio Calabria |
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| | Ospedale Malacrino |
| | Pasquale Iacopino, MD | Principal Investigator |
| | Giuseppe Console, MD | Sub-Investigator |
| | Giuseppe Messina, MD | Sub-Investigator |
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Roma |
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| | Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore |
| | Luca Laurenti, MD | Principal Investigator |
| | Simona Sica, MD | Sub-Investigator |
| | Giovanni Reddiconto, MD | Sub-Investigator |
| | University La Sapienza |
| | Roberto Foà, MD | Principal Investigator |
| | Anna Paola Iori, MD | Sub-Investigator |
| | Giovanni Fernando Torelli, MD | Sub-Investigator |
| | Filippo Milano, MD | Sub-Investigator |
| | Barbarella Lucarelli, MD | Sub-Investigator |
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Rozzano (MI) |
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| | Istituto Clinico Humanitas |
| | Armando Santoro | Principal Investigator |
| | Luca Castagna, MD | Sub-Investigator |
| | Elisabetta Todisco, MD | Sub-Investigator |
| | Barbara Sarina, MD | Sub-Investigator |
| | Rita Mazza, MD | Sub-Investigator |
| | Antonella Anastasia, MD | Sub-Investigator |
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S. Giovanni Rotondo (FG) |
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| | Ospedale Casa Sollievo della Sofferenza |
| | Nicola Cascavilla, MD | Principal Investigator |
| | Michele Mario Greco, MD | Sub-Investigator |
| | Angelo Michele Carella, MD | Sub-Investigator |
| | Michele Nobile, MD | Sub-Investigator |
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Torino |
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| | Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino |
| | Michele Falda, MD | Principal Investigator |
| | Franco Locatelli, MD | Sub-Investigator |
| | Alessandro Busca, MD | Sub-Investigator |
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Udine |
![](https://webarchive.library.unt.edu/eot2008/20090510095403im_/http://www.cancer.gov/images/spacer.gif) |
| | Policlinico Universitario Udine |
| | Renato Fanin, MD | Principal Investigator |
| | Michela Cerno, MD | Sub-Investigator |
| | Alessandra Sperotto, MD | Sub-Investigator |
| | Francesca Patriarca, MD | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00354120 Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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