A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
NCT ID: NCT01056510
Last Updated: 2015-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
357 participants
INTERVENTIONAL
2010-03-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
bendamustine
90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
rituximab [MabThera/Rituxan]
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
B
chlorambucil
10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles
rituximab [MabThera/Rituxan]
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
Interventions
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bendamustine
90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
chlorambucil
10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles
rituximab [MabThera/Rituxan]
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
Eligibility Criteria
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Inclusion Criteria
* chronic lymphocytic leukemia
* active CLL with progressive Binet stage B or C
* ineligible for treatment with fludarabine
* for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
* EOCG performance status \>/=2
Exclusion Criteria
* previous or planned stem cell transplantation
* radioimmunotherapy within 6 months prior to starting study treatment
* transformation to aggressive B-cell malignancy
* any other concurrent anti-cancer therapy, or glucocorticoid \>/=20mg daily prednisolone or equivalent
18 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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Pori, , Finland
Vantaa, , Finland
Argenteuil, , France
Avignon, , France
Blois, , France
Bordeaux, , France
Brest, , France
La Roche-sur-Yon, , France
La Tronche, , France
Le Mans, , France
Lens, , France
Limoges, , France
Lyon, , France
Marseille, , France
Mulhouse, , France
Nice, , France
Nîmes, , France
Paris, , France
Paris, , France
Perpignan, , France
Pierre-Bénite, , France
Salouël, , France
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Porto, , Portugal
Vitoria-Gasteiz, Alava, Spain
Elche, Alicante, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Jerez de la Frontera, Cadiz, Spain
Torrelavega, Cantabria, Spain
Huelva, Huelva, Spain
A Coruña, La Coruña, Spain
León, Leon, Spain
Alcorcón, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Cartagena, Murcia, Spain
Murcia, Murcia, Spain
Murcia, Murcia, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
Tarragona, Tarragona, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Falun, , Sweden
Kristianstad, , Sweden
Luleå, , Sweden
Sundsvall, , Sweden
Uddevalla, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Tunis, , Tunisia
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Edirne, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Kocaeli, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Blackpool, , United Kingdom
Bournemouth, , United Kingdom
Edinburgh, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Maidstone, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Oxford, , United Kingdom
Romford, , United Kingdom
Somerset, , United Kingdom
Truro, , United Kingdom
Countries
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Other Identifiers
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2009-012072-28
Identifier Type: -
Identifier Source: secondary_id
MO22468
Identifier Type: -
Identifier Source: org_study_id
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