Conditions: Follicular Lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

Detailed description:

Arms:
arm 1: VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle arm 2: fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle

Interventions: intervention 1: fludarabine intervention 2: rituximab intervention 3: VELCADE
Intervention descriptions: intervention 1: fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle intervention 2: rituximab 375mg/m2 on Day 1 of every 35-day cycle intervention 3: 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle

Protocol document: