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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 is a Phase 1 study that has completed, run by Aptevo Therapeutics. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01317901
The ClinicalTrials.gov registry entry for NCT01317901 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aptevo Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT01317901 reports 0 study locations.
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.
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