A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
NCT ID: NCT00738374
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2008-11-03
2013-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
chlorambucil
8mg/m2 po on days 1-7 of courses 1-8
Interventions
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rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
chlorambucil
8mg/m2 po on days 1-7 of courses 1-8
Eligibility Criteria
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Inclusion Criteria
* CD20+ chronic lymphocytic leukemia (CLL);
* no previous treatment for CLL;
* ECOG performance status 0-1.
Exclusion Criteria
* history of severe cardiac disease;
* transformation to aggressive B-cell malignancy.
60 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, Italy
Az. Osp. Pugliese; Dh Oncologico
Catanzaro, Calabria, Italy
P.O. Annunziata; U.O. Ematologia
Cosenza, Calabria, Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy
Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Campania, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy
Arcispedale S. Anna; Sezione Di Ematologia
Ferrara, Emilia-Romagna, Italy
Ospedale S. Eugenio; Divisione Di Ematologia
Rome, Lazio, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Rome, Lazio, Italy
Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
Genoa, Liguria, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Turin, Piedmont, Italy
Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I
Turin, Piedmont, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicily, Italy
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicily, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, Italy
A.O. Universitaria Senese; Ematologia
Siena, Tuscany, Italy
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
Padua, Veneto, Italy
Policlinico G. B. Rossi; Divisione Di Ematologia
Verona, Veneto, Italy
Countries
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Other Identifiers
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2008-001612-20
Identifier Type: -
Identifier Source: secondary_id
ML21445
Identifier Type: -
Identifier Source: org_study_id
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