CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
TRU-016 +2 moredrug
Likely dose
TRU-016 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01317901
NCT01317901Phase 1Completed
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A Phase 1 Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma

Aptevo Therapeutics·interventional·Posted Mar 17, 2011·Updated Jun 28, 2017

In Brief

A Phase 1 clinical trial evaluating TRU-016, Bendamustine, and 1 other intervention for B-cell Small Lymphocytic Lymphoma Recurrent. Completed, enrolled 12 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Small Lymphocytic Lymphoma Recurrent
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2011
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.3 years ago

Interventions

TRU-016drug

100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle

Bendamustinedrug

Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.

Rituximabdrug

Rituximab by IV administration at 375 mg/m\^2 on Day 2 of each 28 day cycle.