Trial information
A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-cell Chronic Lymphocytic Leukemia
Status: Not yet recruiting
Protocol number: ML21283
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to assess the effect of maintenance treatment with MabThera vs no treatment, after induction with MabThera, cladribine and cyclophosphamide on progression-free survival in previously untreated patients with progressive B-CLL. The trial conducted with PALG sites
Brief summary: This study will assess the effect of maintenance treatment with MabThera,in comparison with a 2 year observation period (no treatment),in patients with progressive B-cell chronic lymphocytic leukemia who have had previous first-line induction treatment with MabThera (RCC regimen).After 6 months of induction therapy with RCC (MabThera + cladribine + cyclophosphamide) patients will be randomized either to receive maintenance treatment with MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is
200.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Lymphocytic Leukemia, Chronic
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: 1. Progression-free survival in the maintenance phase Time frame: Event driven
Key secondary outcomes: 1. Complete response and partial response in induction phase Time frame: Event driven
Inclusion criteria:
- adult patients, 18-75 years of age;
- confirmed diagnosis of B-cell chronic lymphocytic leukemia;
- stage I-IV disease with evidence of progression;
- no previous chemotherapy, radiotherapy or immunotherapy for B-cell chronic lymphocytic leukemia;
- ECOG PS 0-2.
Exclusion criteria:
- active secondary malignancy or transformation to aggressive lymphoma;
- medical condition requiring chronic use of oral corticosteroids at a dose of 1mg/kg or 60 mg/m2 over 2 weeks;
- prior treatment with interferon, MabThera or another monoclonal antibody, immunosuppressive treatment or radiotherapy for 12 months before study start;
- history of other malignancies within 2 years before study entry, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: October, 2008
Trial registration date: 07/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial will be conducted at the following locations:
Poland
- Bialystok
- Krakow
- Lodz
- Warszawa
- Wroclaw
