Conditions: Lymphoma, Non-Hodgkin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief summary:
This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.

Detailed description:

Arms:
arm 1: 375 mg/m2; One intravenous infusion once a week for 4 weeks arm 2: 375 mg/m2; One intravenous infusion once a week for 4 weeks

Interventions: intervention 1: Rituximab intervention 2: BI 695500
Intervention descriptions: intervention 1: BI 695500 375 mg/M2 intervention 2: BI 695500 375 mg/M2

Protocol document: