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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 is a Phase 1 study that has completed, run by Aptevo Therapeutics. The registered enrollment target is 79 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01188681
The ClinicalTrials.gov registry entry for NCT01188681 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 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 4 interventions - of which Bendamustine is the first listed.
NCT01188681 reports 0 study locations.
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.
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