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NCT01317901 · ClinicalTrials.gov registry record · Phase 1
A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
A Phase 1 study, sponsored by Aptevo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01317901: Completed Phase 1 study, sponsored by Aptevo Therapeutics.
NCT01317901 is a Phase 1 study that has completed, run by Aptevo Therapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01317901, a Phase 1 study, has completed, sponsored by Aptevo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
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 node
Interventions
- DRUG Rituximab
- DRUG Bendamustine
- DRUG TRU-016
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01317901 record still lists
NCT01317901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT01317901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01317901 about?
NCT01317901 is a clinical study titled "A 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 determi...
What is the current status of trial NCT01317901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-05. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01317901?
The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG), TRU-016 (DRUG).
Who is sponsoring clinical trial NCT01317901?
This trial is sponsored by Aptevo Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01317901's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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