B-cell Small Lymphocytic Lymphoma Recurrent Clinical Trial
Official title:
A Phase 1 Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
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.
This study was planned to be conducted in 2 parts: a Phase 1b component designed to
determine a safe dosing regimen, and a Phase 2 component designed to evaluate the efficacy
of BRT compared to BR in subjects with relapsed indolent lymphoma. The Phase 2 component was
not conducted.
This was an open-label, non randomized, multiple-dose escalation study to determine the MTD
of BRT and to determine a safe dosing regimen for the combination in subjects with relapsed
indolent lymphoma.
The study consisted of a screening period lasting up to 21 days, a treatment period lasting
up to 6 cycles (28 days each), and a 60-day follow-up period. Up to 12 subjects (2 cohorts
of 6 subjects each) were planned for enrollment. Two dose levels (10 and 20 mg/kg) of
TRU-016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up
to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1
and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle.
Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects
received study treatment for up to 6 cycles.
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