Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Public ClinicalTrials.gov record NCT01569295. 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 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
Study identification
- NCT ID
- NCT01569295
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 416 participants
Conditions and interventions
Conditions
Interventions
- Idelalisib Drug
- Rituximab Drug
- Bendamustine Drug
- Placebo to match idelalisib 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
- Jun 15, 2012 (Actual)
- Primary completion
- Jun 10, 2019 (Actual)
- Completion
- Jun 10, 2019 (Actual)
- Last update posted
- Mar 10, 2020
2012 – 2019
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Stanford Cancer Center | Palo Alto | California | 94035 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| University of Florida | Gainesville | Florida | 32603 | — |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30322 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Summit Medical Group, P.A. | Morristown | New Jersey | 07962 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Willamette Valley Cancer Center | Eugene | Oregon | 97477 | — |
| Charleston Hematology Oncology | Charleston | South Carolina | 29414 | — |
| Texas Oncology | Austin | Texas | 78731 | — |
| Texas Oncology PA | Dallas | Texas | 75246 | — |
| Texas Oncology | Fort Worth | Texas | 76104 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| Cancer Care Northwest, US Oncology | Spokane | Washington | 99202 | — |
| Virginia Cancer Specialists, PC | Vancouver | Washington | 98684 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 83 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01569295, 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 Mar 10, 2020 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01569295 live on ClinicalTrials.gov.