Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00354120
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2006-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2006-07-19', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 years'}, {'measure': 'Event Free Survival and Disease Free Survival', 'timeFrame': '3 years'}, {'measure': 'Safety:', 'timeFrame': '3 years'}, {'measure': 'Major infective complications (CMV and EBV related PTLD)', 'timeFrame': '3 years'}, {'measure': 'Acute and chronic GvHD', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Haematological and immunologic reconstitution', 'timeFrame': '3 years'}, {'measure': 'Incidence of CMV and EBV reactivation', 'timeFrame': '3 years'}, {'measure': 'Other infective complications', 'timeFrame': '3 years'}, {'measure': 'Other toxicities', 'timeFrame': '3 years'}, {'measure': 'Need for DLI', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Myeloblastic Leukemia', 'Lymphoblastic Leukemia', 'Myelodysplasia', 'Chronic Myeloid Leukemia', 'Myelofibrosis', 'Lympho-proliferative Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://heart.negrisud.it/gitmo/default1.htm', 'label': 'GLOBAL Official Web Site'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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)\n* Group 2: patients \\<= 65 yo suffering from lympho-proliferative diseases according the REAL classification:\n* High-doses chemotherapy relapsed CLL (B and T)\n* Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy\n* Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy\n* Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy\n* Advanced (stage ≥ III A) or relapsed T lymphomas\n* Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens\n* 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\n* 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.\n\nExclusion Criteria:\n\n* Performance status \\< 70% (Karnofsky)\n* Left ventricular cardiac ejection fraction \\< 40% or receiving treatment for heart failure\n* DLCO pulmonary \\< 40% or receiving continuous oxygen therapy\n* Neuropathy (previous or at present)\n* Pregnancy\n* Patients with arterial hypertension not controlled with multi-pharmacological treatments\n* HIV positive\n* B-CLL with clear evidence of transformation into Richter syndrome\n* Mycosis fungoides with clear evidence of transformation into blasts\n* Hodgkin's disease refractory to chemotherapy\n* Absence of informed consent\n* Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment"}, 'identificationModule': {'nctId': 'NCT00354120', 'acronym': 'GLOBAL', 'briefTitle': 'Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Trapianto di Midollo Osseo'}, 'officialTitle': 'Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors', 'orgStudyIdInfo': {'id': 'EudraCT:2005-000805-68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Alentuzumab', 'interventionNames': ['Drug: Alentuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Globulina antilinfocitaria', 'interventionNames': ['Drug: Globulina antilinfocitaria']}], 'interventions': [{'name': 'Alentuzumab', 'type': 'DRUG', 'description': 'Alentuzumab', 'armGroupLabels': ['1']}, {'name': 'Globulina antilinfocitaria', 'type': 'DRUG', 'description': 'Globulina antilinfocitaria', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'Foggia', 'country': 'Italy', 'facility': 'Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Alessandria', 'country': 'Italy', 'facility': 'Divisione Ematologia - Ospedale "SS. Antonio, Biagio e Cesare Arrigo"', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Clinica di Ematologia - Ospedali Riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'Divisione di Ematologia - Ospedali Riuniti Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Cuneo', 'country': 'Italy', 'facility': 'S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Cattedra di Ematologia - Azienda Ospedaliera di Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Divisione di Ematologia - Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Monza', 'country': 'Italy', 'facility': "Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano", 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Divisione Ematologia con trapianto - Ospedale "V. Cervello"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pescara', 'country': 'Italy', 'facility': 'Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Ematologia - Ospedale S. Chiara', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Cattedra di Ematologia - Università La Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano (MI)', 'country': 'Italy', 'facility': 'Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Ematologia 2 - ASO San Giovanni Battista', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'country': 'Italy', 'facility': 'Clinica Ematologica - Policlinico Universitario', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Alessandro Rambaldi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Divisione di Ematologia - Ospedali Riuniti di Bergamo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Trapianto di Midollo Osseo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}