Trial information
A Study of MabThera (Rituximab) in First Line Treatment of Chronic Lymphocytic Leukemia.
Status: Recruiting
Protocol number: ML21135
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the effect of first line treatment with MabThera in combination with fludarabine and cyclophosphamide, followed by MabThera monotherapy, on response rate in patients with chronic lymphocytic leukemia.
Brief summary: This single arm study will assess the efficacy and safety of MabThera in combination with fludarabine and cyclophosphamide, followed by MabThera maintenance therapy, as first line treatment of patients with chronic lymphocytic leukemia. Patients will receive 6 cycles of treatment with MabThera (375mg/m2 i.v. on day 1 of cycle 1, and 500mg/m2 i.v. on day 1 of cycles 2-6), fludarabine (25mg/m2 on days 1-3) and cyclophosphamide (250mg/m2 on days 1-3). Patients with a partial or complete response will receive maintenance treatment with MabThera (375mg/m2 i.v. every 2 months). The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals. Target sample size is 90.
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. Response rate, and percentage of patients with molecular remission Time frame: Event driven
Key secondary outcomes: 1. PFS, overall survival, treatment-free survival. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-70 years of age;
- CD20-positive B-cell chronic lymphocytic leukemia;
- active disease;
- no previous treatment.
Exclusion criteria:
- transformation to aggressive B-cell malignancy;
- history of other malignancies except for localised skin cancer;
- continuous systemic corticosteroid treatment;
- known infection with hepatitis B or C.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 10/15/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Alcala De Henares
- Alcorcon
- Badajoz
- Bilbao
- Caceres
- Cádiz
- Castellon
- Fuenlabrada
- Gandia
- Granada
- Hospitalet de Llobregat
- Jerez De La Frontera
- La Coruna
- Madrid
- Malaga
- Mostoles
- Murcia
- Sagunto
- Salamanca
- Santander
- Valencia
- Vitoria
- Zaragoza
