Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (GLOBAL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Gruppo Italiano Trapianto di Midollo Osseo.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Information provided by:
Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier:
NCT00354120
First received: July 19, 2006
Last updated: October 30, 2009
Last verified: October 2009
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
primary myelofibrosis
MedlinePlus related topics:
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
Drug Information available for:
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 Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Alentuzumab
|
Drug: Alentuzumab
Alentuzumab
|
|
Active Comparator: 2
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 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 | |
| U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena | |
| Milano, Italy | |
| Divisione di Ematologia - Istituto Nazionale dei Tumori | |
| 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 | |
| U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni | |
| Roma, Italy | |
| Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli | |
| 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 | |
| S. Giovanni Rotondo (FG), Italy | |
| Ematologia 2 - ASO San Giovanni Battista | |
| Torino, Italy | |
| 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 |
More Information
No publications provided
| Responsible Party: | Alessandro Rambaldi, GITMO |
| ClinicalTrials.gov Identifier: | NCT00354120 History of Changes |
| Other Study ID Numbers: | EudraCT:2005-000805-68 |
| Study First Received: | July 19, 2006 |
| Last Updated: | October 30, 2009 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Precancerous Conditions Alemtuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013