A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Public ClinicalTrials.gov record NCT01539512. 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 Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
Study identification
- NCT ID
- NCT01539512
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 220 participants
Conditions and interventions
Conditions
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
- Apr 2012 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- May 14, 2019
2012 – 2014
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| Arizona Oncology Associates | Tucson | Arizona | 85704 | — |
| University of California, San Diego- Moores Cancer Center | La Jolla | California | 92093 | — |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | — |
| UCLA | Santa Monica | California | 90404 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| Rocky Mountain Blood and Marrow Transplant Program | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20057 | — |
| Collaborative Medical Research Corporation | Boynton Beach | Florida | 33435 | — |
| Collaborative Research Group LLC | Boynton Beach | Florida | 33435 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | — |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Hematology Oncology Associates of Northern New Jersey | Morristown | New Jersey | 07962 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Willamette Valley Cancer Center | Springfield | Oregon | 97477 | — |
| Northwest Cancer Specialists, PC | Tualatin | Oregon | 97062 | — |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29605 | — |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | — |
| Texas Oncology, P.A. | Fort Worth | Texas | 76104 | — |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | — |
| Cancer Care Network of South Texas | San Antonio | Texas | 78217 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Oncology and Hematology Associates of Southwest Virginia, Inc | Roanoke | Virginia | 24014 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1024 | — |
| Yakima Valley Memorial Hospital / North Star Lodge | Yakima | Washington | 98902 | — |
| 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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01539512, 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 14, 2019 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01539512 live on ClinicalTrials.gov.