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Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00354120
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : March 21, 2014
Information provided by (Responsible Party):
Gruppo Italiano Trapianto di Midollo Osseo

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloblastic Leukemia Lymphoblastic Leukemia Myelodysplasia Chronic Myeloid Leukemia Myelofibrosis Lympho-proliferative Diseases Drug: Alentuzumab Drug: Globulina antilinfocitaria Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: 1
Drug: Alentuzumab

Active Comparator: 2
Globulina antilinfocitaria
Drug: Globulina antilinfocitaria
Globulina antilinfocitaria

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00354120

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Sponsors and Collaborators
Gruppo Italiano Trapianto di Midollo Osseo
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Study Chair: Alessandro Rambaldi, MD Divisione di Ematologia - Ospedali Riuniti di Bergamo
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Responsible Party: Gruppo Italiano Trapianto di Midollo Osseo Identifier: NCT00354120    
Other Study ID Numbers: EudraCT:2005-000805-68
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Myeloid