Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier:
NCT00354120
First received: July 19, 2006
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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
Myelodysplasia
Chronic Myeloid Leukemia
Myelofibrosis
Lympho-proliferative Diseases
Drug: Alentuzumab
Drug: Globulina antilinfocitaria
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Event Free Survival and Disease Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Safety: [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Major infective complications (CMV and EBV related PTLD) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Acute and chronic GvHD [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Haematological and immunologic reconstitution [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Incidence of CMV and EBV reactivation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Other infective complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Other toxicities [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Need for DLI [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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
Alentuzumab
Drug: Alentuzumab
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354120

Locations
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
Firenze, Italy
Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino
Genova, Italy
U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena
Milano, Italy
Divisione di Ematologia - Istituto Nazionale dei Tumori
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
U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni
Roma, Italy
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
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
Investigators
Study Chair: Alessandro Rambaldi, MD Divisione di Ematologia - Ospedali Riuniti di Bergamo
  More Information

No publications provided

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

Additional relevant MeSH terms:
Primary Myelofibrosis
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014