Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant - Full Text View

Sponsor:	Gruppo Italiano Trapianto di Midollo Osseo
Information provided by:	Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier:	NCT00354120

Purpose

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	Intervention	Phase
Acute Myeloblastic Leukemia Lymphoblastic Leukemia Myelodysplasia Chronic Myeloid Leukemia Myelofibrosis Lympho-proliferative Diseases	Drug: Alentuzumab Drug: Globulina antilinfocitaria	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Spleen Diseases

Drug Information available for: Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by Gruppo Italiano Trapianto di Midollo Osseo:

Primary Outcome Measures:

Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Event Free Survival and Disease Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Safety: [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Major infective complications (CMV and EBV related PTLD) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Acute and chronic GvHD [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Haematological and immunologic reconstitution [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Incidence of CMV and EBV reactivation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Other infective complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Other toxicities [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Need for DLI [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Alentuzumab	Drug: Alentuzumab Alentuzumab
2: Active Comparator Globulina antilinfocitaria	Drug: Globulina antilinfocitaria Globulina antilinfocitaria

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354120

Locations

Italy
Divisione di Ematologia - Ospedali Riuniti Bergamo
Bergamo, Italy
Clinica di Ematologia - Ospedali Riuniti di Ancona
Ancona, 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
Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
Rozzano (MI), 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
U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni
Roma, Italy
Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano
Monza, Italy
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
S. Giovanni Rotondo (FG), Italy
Ematologia 2 - ASO San Giovanni Battista
Torino, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"
Alessandria, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Divisione Ematologia con trapianto - Ospedale "V. Cervello"
Palermo, Italy
U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena
Milano, Italy
Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia
Pavia, Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
Modena, Italy
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
Roma, Italy

Sponsors and Collaborators

Gruppo Italiano Trapianto di Midollo Osseo

Investigators

Study Chair:

Alessandro Rambaldi, MD

Divisione di Ematologia - Ospedali Riuniti di Bergamo

More Information

Additional Information:

GLOBAL Official Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GITMO ( Alessandro Rambaldi )
Study ID Numbers:	EudraCT:2005-000805-68
Study First Received:	July 19, 2006
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00354120 History of Changes
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precancerous Conditions
Antineoplastic Agents
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Alemtuzumab
Therapeutic Uses
Myelofibrosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases

Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Pharmacologic Actions
Myeloid Metaplasia
Lymphatic Diseases
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders
Splenic Diseases

ClinicalTrials.gov processed this record on February 08, 2010