Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
- Conditions
- Health Condition 1: null- Follicular Lymphoma Patients Previously Treated With Rituximab
- Registration Number
- CTRI/2009/091/000743
- Lead Sponsor
- Johnson Johnson Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Male or female subjects 18 years or older Histologically proven diagnosis of follicular nonHodgkins lymphoma grades 1 or 2 according to the World Health Organization classification Subjects must have received at least 12 doses 375mgperm2 or appropriately adjusted dose of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab containing regimens as documented in the subjects medical record documented relapse or progression following last antineoplastic treatment
At least 1 measurable tumor mass 150 mm by 100 mm
Subjects with histological or clinical transformation to an aggressive lymphoma
prior treatment with VELCADE or fludarabine.
antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
nitrosoureas within 6 weeks before randomization
radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
major surgery within 3 weeks before randomization
chronic use of corticosteroids, such as dexamethasone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method