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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	18 to 65	Other	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)

• Pregnancy

• Patients with arterial hypertension not controlled with multi-pharmacological treatments

• HIV positive

• 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

Study Chair

Roberto Marchioli, MD		Ph: +39-0872-570324
		Email: marchioli@negrisud.it

Italy
	Alessandria
	Ospedale SS. Biagio e Arrigo
		Alessandro Levis	Principal Investigator
		Bernardino Allione, MD	Sub-Investigator
		Flavia Salvi, MD	Sub-Investigator
	Ancona
	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
	Bergamo
	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
	Cuneo
	Ospedale Santa Croce
		Andrea Gallamini	Principal Investigator
		Nicola Mordini, MD	Sub-Investigator
		Daniele Mattei, MD	Sub-Investigator
	Firenze
	Azienda Ospedaliero Careggi
		Alberto Bosi, MD	Principal Investigator
		Letizia Lombardini, MD	Sub-Investigator
		Stefano Guidi, MD	Sub-Investigator
		Chiara Nozzoli, MD	Sub-Investigator
	Milano
	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
	Pavia
	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
	Pescara
	Ospedale Civile Pescara
		Paolo Di Bartolomeo, MD	Principal Investigator
		Stella Santarone, MD	Sub-Investigator
		Gabriele Papalinetti, MD	Sub-Investigator
	Pisa
	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
	Reggio Calabria
	Ospedale Malacrino
		Pasquale Iacopino, MD	Principal Investigator
		Giuseppe Console, MD	Sub-Investigator
		Giuseppe Messina, MD	Sub-Investigator
	Roma
	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
	Rozzano (MI)
	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
	S. Giovanni Rotondo (FG)
	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
	Torino
	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
		Michele Falda, MD	Principal Investigator
		Franco Locatelli, MD	Sub-Investigator
		Alessandro Busca, MD	Sub-Investigator
	Udine
	Policlinico Universitario Udine
		Renato Fanin, MD	Principal Investigator
		Michela Cerno, MD	Sub-Investigator
		Alessandra Sperotto, MD	Sub-Investigator
		Francesca Patriarca, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00354120
Information obtained from ClinicalTrials.gov on March 18, 2009