Trial information
A Study to Evaluate MabThera (Rituximab) in Patients Previously Treated for Chronic Lymphocytic Leukemia
Status: No longer recruiting
Protocol number: BO17072
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study comparing the effect of MabThera, with and without fludarabine/ cyclophosphamide, on progression-free survival and safety in patients with previously treated B-cell chronic lymphocytic leukemia
Brief summary: This study will assess the efficacy and safety of adding MabThera to chemotherapy in patients with previously treated B-cell chronic lymphocytic leukemia (B-CLL) . The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Target sample size is 550.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Lymphocytic Leukemia, Chronic
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Efficacy: Progression-free survival.
Key secondary outcomes: 1. Efficacy: Event free survival; disease-free survival; response duration; response rate; overall survival; proportion of patients with molecular remission.
Safety: Adverse events and clinical laboratory safety tests
Inclusion criteria:
- adult patients >=18 years of age;
- CD20-positive B-cell chronic lymphocytic leukemia;
- previous treatment for CLL;
- women of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.
Exclusion criteria:
- previous treatment with interferon, MabThera, or another monoclonal antibody;
- previous bone marrow transplant;
- a history of other malignancies within 2 years prior to study entry;
- transformation to aggressive B-cell malignancy;
- fertile men, and women of childbearing potential, not using adequate contraception throughout the study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2003
Trial registration date: 06/24/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Frankston
- Melbourne
- Sydney
Belgium
- Antwerpen
- Bruxelles
- Leuven
Canada
- Edmonton, AB
- Vancouver, BC
- Halifax, NS
- Ottawa, ON
- Toronto, ON
Denmark
France
- Caen
- Clermont-Ferrand
- Creteil
- Le Mans
- Lille
- Lyon
- Marseille
- Montpellier
- Nantes
- Paris
- Pierre Benite
- Rouen
- Tours
- Vandoeuvre-Les-Nancy
Hungary
- Budapest
- Debrecen
- Pecs
- Szeged
Italy
- Bari
- Bologna
- Milano
- Napoli
- Pavia
- Roma
- Vicenza
Netherlands
- Amersfoort
- Amsterdam
- Den Haag
- Rotterdam
New Zealand
- Auckland
- Christchurch
- Wellington
Norway
Poland
Romania
- Bucharest
- Targu-Mures
- Timisoara
Russian Federation
- Moscow
- Obninsk
- Samara
- St Petersburg
Spain
- Madrid
- Salamanca
- Zaragoza
Sweden
United Kingdom
- Bournemouth
- Cambridge
- Glasgow
- Leeds
- Liverpool
- London
United States
