Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)

March 9, 2023 updated by: Gruppo Italiano Trapianto di Midollo Osseo

Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"
      • Ancona, Italy
        • Clinica di Ematologia - Ospedali Riuniti di Ancona
      • Bergamo, Italy
        • Divisione di Ematologia - Ospedali Riuniti Bergamo
      • Cuneo, Italy
        • S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
      • Firenze, Italy
        • Cattedra di Ematologia - Azienda Ospedaliera di Careggi
      • Genova, Italy
        • Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino
      • Milano, 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
      • Modena, Italy
        • Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
      • Monza, Italy
        • Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano
      • Palermo, Italy
        • Divisione Ematologia con trapianto - Ospedale "V. Cervello"
      • Pavia, Italy
        • Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia
      • Pescara, Italy
        • Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
      • Pisa, Italy
        • Ematologia - Ospedale S. Chiara
      • Reggio Calabria, Italy
        • Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
      • Roma, Italy
        • Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
      • Roma, 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
      • Rozzano (MI), Italy
        • Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
      • Torino, Italy
        • Ematologia 2 - ASO San Giovanni Battista
      • Udine, Italy
        • Clinica Ematologica - Policlinico Universitario
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Alentuzumab
Drug: Alentuzumab
Alentuzumab
Active Comparator: 2
Globulina antilinfocitaria
Drug: Globulina antilinfocitaria
Globulina antilinfocitaria

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Haematological and immunologic reconstitution
Time Frame: 3 years
3 years
Incidence of CMV and EBV reactivation
Time Frame: 3 years
3 years
Other infective complications
Time Frame: 3 years
3 years
Other toxicities
Time Frame: 3 years
3 years
Need for DLI
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Trapianto di Midollo Osseo

Investigators

  • Study Chair: Alessandro Rambaldi, MD, Divisione di Ematologia - Ospedali Riuniti di Bergamo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT:2005-000805-68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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