Chronic Myeloid Leukemia Clinical Trial
— GLOBALOfficial title:
Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors
Verified date | March 2023 |
Source | Gruppo Italiano Trapianto di Midollo Osseo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Trapianto di Midollo Osseo |
Italy,
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 |
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