Health Condition 1: null- Follicular Lymphoma Patients Previously Treated With Rituximab
Conditions
Interventions
Intervention1: Velcade: IV, 1.6 mg/m2,weekly x4
Intervention2: Fludarabine: 40mg/m2/day orally,
Control Intervention1: Rituximab: 375mg/m2, IV, 4 weekly x 1
Control Intervention2: Fludarabine: 40mg/
Sponsors
Johnson Johnson Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rateTimepoint: [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of responseTimepoint: Up to 8 cycles (1 cycle is 35 days: 280 days);Overall Response RateTimepoint: Up to 8 cycles (1 cycle is 35 days: 280 days);Overall survivalTimepoint: Up to 8 cycles (1 cycle is 35 days: 280 days);Progression-free survivalTimepoint: Up to 8 cycles (1 cycle is 35 days: 280 days);Time to progressionTimepoint: Up to 8 cycles (1 cycle is 35 days: 280 days) | — |
Countries
France, Germany, Greece, India, Israel, Italy, Spain, Switzerland
Contacts
Public ContactDr Jitendra R Dixit
Johnson & Johnson Limited
Outcome results
None listed