BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Status:
Terminated
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.