Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

Chronic Myeloid Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354120
• Other study ID #: EudraCT:2005-000805-68
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2005
• Est. completion date: August 2011

Study information

• Verified date: March 2023
• Source: Gruppo Italiano Trapianto di Midollo Osseo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloblastic Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid, Acute
• Lympho-proliferative Diseases
• Lymphoblastic Leukemia
• Lymphoproliferative Disorders
• Myelodysplasia
• Myelofibrosis

Intervention

Drug:
• Alentuzumab
Alentuzumab
• Globulina antilinfocitaria
Globulina antilinfocitaria

Locations

Country	Name	City	State
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	Divisione di Ematologia - Istituto Nazionale dei Tumori	Milano
Italy	U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena	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	Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli	Roma
Italy	U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni	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	San Giovanni Rotondo	Foggia
Italy	Ematologia 2 - ASO San Giovanni Battista	Torino
Italy	Clinica Ematologica - Policlinico Universitario	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Trapianto di Midollo Osseo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		3 years
Primary	Event Free Survival and Disease Free Survival		3 years
Primary	Safety:		3 years
Primary	Major infective complications (CMV and EBV related PTLD)		3 years
Primary	Acute and chronic GvHD		3 years
Secondary	Haematological and immunologic reconstitution		3 years
Secondary	Incidence of CMV and EBV reactivation		3 years
Secondary	Other infective complications		3 years
Secondary	Other toxicities		3 years
Secondary	Need for DLI		3 years

External Links

•   GLOBAL Official Web Site