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NCT01188681 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Aptevo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT01188681: Completed Phase 1 study, sponsored by Aptevo Therapeutics.
NCT01188681 is a Phase 1 study that has completed, run by Aptevo Therapeutics. The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188681, a Phase 1 study, has completed, sponsored by Aptevo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL.
Primary Outcome
Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements,
Interventions
- DRUG Bendamustine
- DRUG TRU-016 and bendamustine
- DRUG 15 mg/kg TRU-016 and bendamustine
- DRUG 20 mg/kg TRU-016 and bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01188681 record still lists
NCT01188681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 4 interventions - of which Bendamustine is the first listed.
NCT01188681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01188681 about?
NCT01188681 is a clinical study titled "Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia". The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to be...
What is the current status of trial NCT01188681?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2010-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01188681?
The interventions under investigation include: Bendamustine (DRUG), TRU-016 and bendamustine (DRUG), 15 mg/kg TRU-016 and bendamustine (DRUG), 20 mg/kg TRU-016 and bendamustine (DRUG).
Who is sponsoring clinical trial NCT01188681?
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 NCT01188681's enrollment target sits among peer trials
79 696th of 2000 higher than 1,304 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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