Clinical trialNCT01317901CompletedPhase 1Interventional

A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma

SponsorAptevo TherapeuticsEnrollment12B-cell Small Lymphocytic Lymphoma Recurrent

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Scott Stromatt, MD
Aptevo Therapeutics
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Site Reference Id/investigator# 61543
Birmingham, Alabama, United States
Site Reference Id/investigator# 61542
Augusta, Georgia, United States
Site Reference Id/investigator# 61523
Omaha, Nebraska, United States
Site Reference Id/investigator# 61522
Hackensack, New Jersey, United States
Site Reference Id/investigator# 61544
Chapel Hill, North Carolina, United States
Site Reference Id/investigator# 61524
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BendamustineRituximabTRU-016

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2011
Primary completion: 30 Apr 2013
Completion: 30 Jun 2013
Last update posted: 28 Jun 2017
Registered enrollment: 12
Registry id: NCT01317901

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.