Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
Public ClinicalTrials.gov record NCT01539291. 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, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia A Companion Trial to Study GS-US-312-0116: 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.
The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.
Study identification
- NCT ID
- NCT01539291
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 161 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
- Oct 3, 2012 (Actual)
- Primary completion
- May 21, 2018 (Actual)
- Completion
- Jun 29, 2018 (Actual)
- Last update posted
- Aug 20, 2019
2012 – 2018
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 27
| 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 | 20007 | — |
| Collaborative Research Group | Boynton Beach | Florida | 33435 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | — |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| 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 Research Institute | 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 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01539291, 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 Aug 20, 2019 · 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 NCT01539291 live on ClinicalTrials.gov.