A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
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|ClinicalTrials.gov Identifier: NCT01317901|
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : October 6, 2016
Last Update Posted : June 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|B-cell Small Lymphocytic Lymphoma Recurrent||Drug: TRU-016 Drug: Bendamustine Drug: Rituximab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||June 2013|
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.
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
Other Name: otlertuzumab
Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.
Other Name: Treanda
Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle.
Other Name: rituxan
- Response [ Time Frame: Day 15 and Day 28 of even-numbered cycles ]Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317901
|United States, Alabama|
|Site Reference ID/Investigator# 61543|
|Birmingham, Alabama, United States, 35294|
|United States, Georgia|
|Site Reference ID/Investigator# 61542|
|Augusta, Georgia, United States, 30912|
|United States, Nebraska|
|Site Reference ID/Investigator# 61523|
|Omaha, Nebraska, United States, 68114|
|United States, New Jersey|
|Site Reference ID/Investigator# 61522|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Site Reference ID/Investigator# 61544|
|Chapel Hill, North Carolina, United States, 27599-7305|
|United States, Washington|
|Site Reference ID/Investigator# 61524|
|Seattle, Washington, United States, 98109-1023|
|Study Director:||Scott Stromatt, MD||Aptevo Therapeutics|