Trial information
A Study of MabThera (Rituximab) plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Status: Recruiting
Protocol number: ML21445
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A study of chlorambucil plus MabThera as induction therapy followed in responders by maintenance therapy versus observation on response rate in patients >=60 years with previously untreated chronic lymphocytic leukemia
Brief summary: This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is <100 indivduals. 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. Overall tumor response at end of induction phase Time frame: 10 months
Key secondary outcomes: 1. Complete response, partial response at end of induction phase Time frame: 10 months
2. Overall tumor response, complete response, partial response at end of maintenance phase Time frame: 35 months
3. Event-free survival, progression-free survival, duration of response, disease-free survival, overall survival, time to new treatment or death. Time frame: Event driven
4. AEs, laboratory parameters, ECG, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=60 years of age;
- CD20+ chronic lymphocytic leukemia (CLL);
- no previous treatment for CLL;
- ECOG performance status 0-1.
Exclusion criteria:
- co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
- history of severe cardiac disease;
- transformation to aggressive B-cell malignancy.
Gender: Males or Females
Age limits: Min: 60 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2008
Trial registration date: 08/15/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
- Bari
- Bologna
- Catania
- Catanzaro
- Cosenza
- Ferrara
- Firenze
- Genova
- Messina
- Milano
- Napoli
- Padova
- Reggio Calabria
- Roma
- Siena
- Torino
- Verona
