Phase 1b Safety and Efficacy Study of TRU-016
Public ClinicalTrials.gov record NCT01644253. 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
Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.
Study identification
- NCT ID
- NCT01644253
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 87 participants
Conditions and interventions
Interventions
- 20 mg/kg TRU-016 + Rituximab Biological
- 10 mg/kg TRU-016 + Rituximab Biological
- TRU-016 20 mg/kg + Obinutuzumab Biological
- TRU-016 6-20 mg/kg + idelalisib + rituximab Biological
- TRU-016 10-20 mg/kg + ibrutinib Biological
- TRU-016 10-20 mg/kg + bendamustine Biological
Biological
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, 2012
- Primary completion
- Feb 23, 2020
- Completion
- Apr 20, 2021
- Last update posted
- May 19, 2021
2012 – 2021
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Augusta | Georgia | 30912 | — |
| Not listed | Columbus | Ohio | 43210 | — |
| Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Not listed | Houston | Texas | 77030 | — |
| Swedish Cancer Institute,1221 Madison St. | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Research Center | 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.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01644253, 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 May 19, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01644253 live on ClinicalTrials.gov.