Trial information
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Chronic Lymphocytic Leukemia.
Status: Recruiting
Protocol number: MO20927
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to characterize the safety and response rate of MabThera (Rituximab) plus chlorambucil in previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia
Brief summary: This single arm study will assess the safety and effect on response rate of a combination of MabThera and chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia. Patients will receive 6x monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. MabThera will be administered on day 1 of each cycle, at a dose of 375mg/m2 iv in cycle 1, and 500mg/m2 in subsequent cycles, and chlorambucil will be administered on days 1-7 of each cycle at a dose of 10mg/m2/day po. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 100.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Lymphocytic Leukemia, Chronic
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: 1. AE profile; laboratory parameters Time frame: Throughout study
Key secondary outcomes: 1. Tumor response rate, PFS, DFS, duration of response, overall survival, molecular remission. Time frame: Event driven
Inclusion criteria:
- adult patients, >=18 years of age;
- previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia;
- patients with progressive Binet stage B, or C requiring therapy according to NCI criteria;
- ECOG performance status <=2.
Exclusion criteria:
- previous treatment for CLL;
- known concomitant hematological malignancy;
- transformation to aggressive B-cell malignancy;
- history of severe cardiac disease;
- known hypersensitivity or anaphylactic reactions to murine antibodies.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 09/17/2007
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
United Kingdom
- Birmingham
- Bournemouth
- Cambridge
- Canterbury
- Hull
- Leeds
- Leicester
- Liverpool
- London
- Sutton
- Wakefield
