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GLOBAL: Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

Sponsor
Gruppo Italiano Trapianto di Midollo Osseo (Other)
Overall Status
Completed
CT.gov ID
NCT00354120
Collaborator
(none)
121
Enrollment
22
Locations
2
Arms
77
Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Mar 1, 2005
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Alentuzumab

Drug: Alentuzumab
Alentuzumab
Active Comparator: 2

Globulina antilinfocitaria

Drug: Globulina antilinfocitaria
Globulina antilinfocitaria

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [3 years]

  2. Event Free Survival and Disease Free Survival [3 years]

  3. Safety: [3 years]

  4. Major infective complications (CMV and EBV related PTLD) [3 years]

  5. Acute and chronic GvHD [3 years]

Secondary Outcome Measures

  1. Haematological and immunologic reconstitution [3 years]

  2. Incidence of CMV and EBV reactivation [3 years]

  3. Other infective complications [3 years]

  4. Other toxicities [3 years]

  5. Need for DLI [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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

Locations

Site City State Country Postal Code
1 Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo" Alessandria Italy
2 Clinica di Ematologia - Ospedali Riuniti di Ancona Ancona Italy
3 Divisione di Ematologia - Ospedali Riuniti Bergamo Bergamo Italy
4 S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle Cuneo Italy
5 Cattedra di Ematologia - Azienda Ospedaliera di Careggi Firenze Italy
6 Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino Genova Italy
7 Divisione di Ematologia - Istituto Nazionale dei Tumori Milano Italy
8 U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena Milano Italy
9 Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico - Modena Italy
10 Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano Monza Italy
11 Divisione Ematologia con trapianto - Ospedale "V. Cervello" Palermo Italy
12 Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia Pavia Italy
13 Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara Pescara Italy
14 Ematologia - Ospedale S. Chiara Pisa Italy
15 Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli Reggio Calabria Italy
16 Cattedra di Ematologia - Università La Sapienza Roma Italy
17 Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli Roma Italy
18 U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni Roma Italy
19 Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas Rozzano (MI) Italy
20 Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza S. Giovanni Rotondo (FG) Italy
21 Ematologia 2 - ASO San Giovanni Battista Torino Italy
22 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier:
NCT00354120
Other Study ID Numbers:
  • EudraCT:2005-000805-68
First Posted:
Jul 20, 2006
Last Update Posted:
Mar 21, 2014
Last Verified:
Mar 1, 2014
Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Lymphoproliferative Disorders

Study Results

No Results Posted as of Mar 21, 2014