Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
Public ClinicalTrials.gov record NCT01188681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2 Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Bendamustine vs. Bendamustine Alone in Patients With Relapsed Chronic Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01188681
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 79 participants
Conditions and interventions
Conditions
Interventions
- TRU-016 and bendamustine Drug
- Bendamustine Drug
- 15 mg/kg TRU-016 and bendamustine Drug
- 20 mg/kg TRU-016 and bendamustine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2010
- Primary completion
- Nov 30, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Jun 9, 2021
2010 – 2014
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| For additional information regarding sites for this trial call (919) 465-4648 | Denver | Colorado | 80218 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Augusta | Georgia | 30912 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Chicago | Illinois | 60637 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Hackensack | New Jersey | 07601 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Syracuse | New York | 13210 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Durham | North Carolina | 27710 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Cleveland | Ohio | 44195 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Columbus | Ohio | 43210 | — |
| For additional information regarding sites for this trial call (919) 465-4648 | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01188681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01188681 live on ClinicalTrials.gov.