Conditions: Follicular Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 73
Healthy volunteers: no

Brief summary:
This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Detailed description:

Arms:
arm 1: This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Interventions: intervention 1: VELCADE intervention 2: Bendamustine intervention 3: Rituximab
Intervention descriptions: intervention 1: VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle. intervention 2: Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle intervention 3: Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5

Protocol document: