Trial information
A Study of MabThera (Rituximab) in Combination Chemotherapy in Patients With B-Cell Chronic Lymphocytic Leukemia
Status: Completed
Protocol number: M39024
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: Measurement of response rate and time to disease progression in patients with chronic lymphocytic leukemia using fludarabine and the anti-CD20 antibody rituximab (IDEC-C2B8)
Brief summary: This study will evaluate the efficacy and safety of MabThera in combination with fludarabine in patients with B-cell chronic lymphocytic leukemia. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 30.
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. Efficacy: response rate, time to disease progression. Safety: adverse events, number of infections.
Key secondary outcomes: 1. Overall ISR summary score; AEs and ISR leading to discontinuation; SAEs; deaths; patient satisfaction/preference; adherence.
Inclusion criteria:
- adult patients 18-75 years of age;
- B-cell chronic lymphocytic leukemia, stages B and C;
- at first diagnosis or after treatment with chlorambucil, prednisone, or a combination of both
Exclusion criteria:
- previous treatment with murine antibodies;
- clinically significant cardiac disease;
- history of malignancy other than squamous cell cancer, basal cell cancer of the skin, or cancer in situ of the cervix in the last 5 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Erfurt
- Grenzach-Wyhlen
- Heidelberg
- Köln
- Stuttgart
