Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
NCT ID: NCT00354120
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
121 participants
INTERVENTIONAL
2005-03-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Alentuzumab
Alentuzumab
Alentuzumab
2
Globulina antilinfocitaria
Globulina antilinfocitaria
Globulina antilinfocitaria
Interventions
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Alentuzumab
Alentuzumab
Globulina antilinfocitaria
Globulina antilinfocitaria
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Gruppo Italiano Trapianto di Midollo Osseo
OTHER
Responsible Party
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Principal Investigators
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Alessandro Rambaldi, MD
Role: STUDY_CHAIR
Divisione di Ematologia - Ospedali Riuniti di Bergamo
Locations
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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
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
Countries
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Related Links
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GLOBAL Official Web Site
Other Identifiers
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EudraCT:2005-000805-68
Identifier Type: -
Identifier Source: org_study_id
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