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Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)

Primary Purpose

Acute Myeloblastic Leukemia, Lymphoblastic Leukemia, Myelodysplasia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Alentuzumab
Globulina antilinfocitaria
Sponsored by
Gruppo Italiano Trapianto di Midollo Osseo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloblastic Leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
  • Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"
  • Clinica di Ematologia - Ospedali Riuniti di Ancona
  • Divisione di Ematologia - Ospedali Riuniti Bergamo
  • S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
  • Cattedra di Ematologia - Azienda Ospedaliera di Careggi
  • Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino
  • Divisione di Ematologia - Istituto Nazionale dei Tumori
  • U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena
  • Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
  • Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano
  • Divisione Ematologia con trapianto - Ospedale "V. Cervello"
  • Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia
  • Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
  • Ematologia - Ospedale S. Chiara
  • Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
  • Cattedra di Ematologia - Università La Sapienza
  • Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
  • U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni
  • Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
  • Ematologia 2 - ASO San Giovanni Battista
  • Clinica Ematologica - Policlinico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Alentuzumab

Globulina antilinfocitaria

Outcomes

Primary Outcome Measures

Overall Survival
Event Free Survival and Disease Free Survival
Safety:
Major infective complications (CMV and EBV related PTLD)
Acute and chronic GvHD

Secondary Outcome Measures

Haematological and immunologic reconstitution
Incidence of CMV and EBV reactivation
Other infective complications
Other toxicities
Need for DLI

Full Information

First Posted
July 19, 2006
Last Updated
March 9, 2023
Sponsor
Gruppo Italiano Trapianto di Midollo Osseo
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1. Study Identification

Unique Protocol Identification Number
NCT00354120
Brief Title
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Acronym
GLOBAL
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Trapianto di Midollo Osseo

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloblastic Leukemia, Lymphoblastic Leukemia, Myelodysplasia, Chronic Myeloid Leukemia, Myelofibrosis, Lympho-proliferative Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Alentuzumab
Arm Title
2
Arm Type
Active Comparator
Arm Description
Globulina antilinfocitaria
Intervention Type
Drug
Intervention Name(s)
Alentuzumab
Intervention Description
Alentuzumab
Intervention Type
Drug
Intervention Name(s)
Globulina antilinfocitaria
Intervention Description
Globulina antilinfocitaria
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
Event Free Survival and Disease Free Survival
Time Frame
3 years
Title
Safety:
Time Frame
3 years
Title
Major infective complications (CMV and EBV related PTLD)
Time Frame
3 years
Title
Acute and chronic GvHD
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Haematological and immunologic reconstitution
Time Frame
3 years
Title
Incidence of CMV and EBV reactivation
Time Frame
3 years
Title
Other infective complications
Time Frame
3 years
Title
Other toxicities
Time Frame
3 years
Title
Need for DLI
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Rambaldi, MD
Organizational Affiliation
Divisione di Ematologia - Ospedali Riuniti di Bergamo
Official's Role
Study Chair
Facility Information:
Facility Name
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"
City
Alessandria
Country
Italy
Facility Name
Clinica di Ematologia - Ospedali Riuniti di Ancona
City
Ancona
Country
Italy
Facility Name
Divisione di Ematologia - Ospedali Riuniti Bergamo
City
Bergamo
Country
Italy
Facility Name
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
City
Cuneo
Country
Italy
Facility Name
Cattedra di Ematologia - Azienda Ospedaliera di Careggi
City
Firenze
Country
Italy
Facility Name
Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino
City
Genova
Country
Italy
Facility Name
Divisione di Ematologia - Istituto Nazionale dei Tumori
City
Milano
Country
Italy
Facility Name
U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena
City
Milano
Country
Italy
Facility Name
Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
City
Modena
Country
Italy
Facility Name
Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano
City
Monza
Country
Italy
Facility Name
Divisione Ematologia con trapianto - Ospedale "V. Cervello"
City
Palermo
Country
Italy
Facility Name
Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia
City
Pavia
Country
Italy
Facility Name
Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
City
Pescara
Country
Italy
Facility Name
Ematologia - Ospedale S. Chiara
City
Pisa
Country
Italy
Facility Name
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
City
Reggio Calabria
Country
Italy
Facility Name
Cattedra di Ematologia - Università La Sapienza
City
Roma
Country
Italy
Facility Name
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
City
Roma
Country
Italy
Facility Name
U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni
City
Roma
Country
Italy
Facility Name
Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
City
Rozzano (MI)
Country
Italy
Facility Name
Ematologia 2 - ASO San Giovanni Battista
City
Torino
Country
Italy
Facility Name
Clinica Ematologica - Policlinico Universitario
City
Udine
Country
Italy

12. IPD Sharing Statement

Links:
URL
https://heart.negrisud.it/gitmo/default1.htm
Description
GLOBAL Official Web Site

Learn more about this trial

Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

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