A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in subjects
with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study to
determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and
bendamustine and to determine a safe dosing regimen for the combination in up to 12 subjects
with relapsed indolent lymphoma.
The originally planned Phase 2 portion, an open-label, randomized study to evaluate the
efficacy of BRT compared with BR, was not conducted.
Phase:
Phase 1
Details
Lead Sponsor:
Aptevo Therapeutics
Treatments:
Bendamustine Hydrochloride Immunoglobulin G Rituximab