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Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)

This study has been completed.
Information provided by (Responsible Party):
Gruppo Italiano Trapianto di Midollo Osseo Identifier:
First received: July 19, 2006
Last updated: March 20, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Acute Myeloblastic Leukemia
Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Lympho-proliferative Diseases
Drug: Alentuzumab
Drug: Globulina antilinfocitaria
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Gruppo Italiano Trapianto di Midollo Osseo:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years ]
  • Event Free Survival and Disease Free Survival [ Time Frame: 3 years ]
  • Safety: [ Time Frame: 3 years ]
  • Major infective complications (CMV and EBV related PTLD) [ Time Frame: 3 years ]
  • Acute and chronic GvHD [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Haematological and immunologic reconstitution [ Time Frame: 3 years ]
  • Incidence of CMV and EBV reactivation [ Time Frame: 3 years ]
  • Other infective complications [ Time Frame: 3 years ]
  • Other toxicities [ Time Frame: 3 years ]
  • Need for DLI [ Time Frame: 3 years ]

Enrollment: 121
Study Start Date: March 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Alentuzumab
Active Comparator: 2
Globulina antilinfocitaria
Drug: Globulina antilinfocitaria
Globulina antilinfocitaria

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00354120

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 e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
S. Giovanni Rotondo (FG), Italy
Ematologia 2 - ASO San Giovanni Battista
Torino, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Sponsors and Collaborators
Gruppo Italiano Trapianto di Midollo Osseo
Study Chair: Alessandro Rambaldi, MD Divisione di Ematologia - Ospedali Riuniti di Bergamo
  More Information

Responsible Party: Gruppo Italiano Trapianto di Midollo Osseo Identifier: NCT00354120     History of Changes
Other Study ID Numbers: EudraCT:2005-000805-68
Study First Received: July 19, 2006
Last Updated: March 20, 2014

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Primary Myelofibrosis
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Myeloid
Precancerous Conditions
Antineoplastic Agents processed this record on April 27, 2017