Trial information
A Study of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia (CLL) Responsive to First Line Therapy
Status: Completed
Protocol number: M39052
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the clinical and biologic responses to MabThera in patients with chronic lymphocytic leukemia responsive to first-line treatment with chlorambucil and prednisone
Brief summary: This study will evaluate the efficacy and safety of MabThera in patients with CLL with partial or complete remission after first-line treatment with chlorambucil and prednisone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is 20.
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. Rate of clinical and biologic response at 1 month after end of treatment
Key secondary outcomes: 1. Clinical and biologic disease-free survival at 3 years' follow-up, event-free survival, and overall survival; CTC toxicity and AEs
Inclusion criteria:
- adults >60 years;
- CLL, in complete or partial response after 6 courses of chlorambucil and prednisolone.
Exclusion criteria:
- history of malignancy, except for non-metastatic basal or squamous cell cancer of the skin;
- positive test result for HIV or for hepatitis B or C;
- uncontrolled hypertension or cardiac disease.
Gender: Males or Females
Age limits: Min: 60 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
