Trial information
CHAIROS study A Study of MabThera (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
Status: No longer recruiting
Protocol number: ML18434
Sponsor: Roche Austria GmbH
Company division: Pharmaceutical
Official Scientific Title: CHAIROS - Effect of early brief intensification by chemoimmunotherapy with FCR followed by FR and Rituximab maintenance on clinical response in chemo-naïve patients with B-CLL
Brief summary: This study will evaluate the efficacy and safety of intense combination treatment including MabThera, followed by MabThera maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals. Target sample size is
40.
Study phase: IV
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. Complete response rate.
Key secondary outcomes: 1. Clinical efficacy (complete and partial response) after induction and maintenance therapy; molecular complete response; hematologic and non-hematologic toxicities
Inclusion criteria:
- adult patients >=18 years of age;
- B-cell CLL;
- no previous chemotherapy, radiotherapy, or immunotherapy.
Exclusion criteria:
- positive Coombs test, and/or autoimmune haemolytic anemia;
- reduced organ function, or bone marrow dysfunction not due to CLL;
- patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- patients with a history of severe cardiac disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2005
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Austria
- Bludesch
- Innsbruck
- Leoben
- Linz
- Salzburg
- Wels
