Trial information
A Study of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia (CLL)
Status: Recruiting
Protocol number: ML18429
Sponsor: Productos Roche, SAQeI Argentina
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of MabThera plus fludarabine and cyclophosphamide on progression-free survival in patients with B-cell chronic lymphocytic leukemia
Brief summary: This study will evaluate the efficacy and safety of MabThera in combination with chemotherapy in patients with B-cell CLL. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 15.
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. Progression-free survival, overall survival, and objective response
Key secondary outcomes: 1. Adverse events, clinical laboratory tests of safety, and vital signs
Inclusion criteria:
- adult patients >=18 years of age;
- B-cell CLL;
- no previous treatment for leukemia.
Exclusion criteria:
- history of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer;
- co-morbid condition requiring long-term (>1 month) systemic corticosteroids during study treatment;
- known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2006
Trial registration date: 08/29/2005
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Argentina
- Buenos Aires
- Córdoba
- La Plata
- Pilar
- Rosario
Venezuela
