Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Public ClinicalTrials.gov record NCT01732913. 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 Indolent Non-Hodgkin Lymphomas
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 to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Study identification
- NCT ID
- NCT01732913
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 295 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
- Jan 16, 2013 (Actual)
- Primary completion
- May 18, 2016 (Actual)
- Completion
- May 18, 2016 (Actual)
- Last update posted
- Nov 16, 2018
2013 – 2016
United States locations
- U.S. sites
- 32
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| Ironwood Cancer and Research Center | Chandler | Arizona | 85224 | — |
| City of Hope Cancer Center | Duarte | California | 91010 | — |
| Saint Jude Heritage Healthcare | Fullerton | California | 92835 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Cancer Care Associates | Redondo Beach | California | 90277 | — |
| Cancer Center of Santa Barbara | Santa Barbara | California | 93105 | — |
| Central Coast Medical Oncology Group | Santa Maria | California | 93454 | — |
| Middlesex Hospital Cancer Center | Middletown | Connecticut | 06457 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Florida Cancer Specialists and Research Institute | Fort Myers | Florida | 33916 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169-3321 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Prairie Lakes Healthcare System | Watertown | South Dakota | 57252 | — |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37404 | — |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | — |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Center for Cancer and Blood Disorders, PC | Fort Worth | Texas | 76104 | — |
| Shenandoah Oncology Associates, PC | Winchester | Virginia | 22601 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
| Froedtert Hospital and 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 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01732913, 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 Nov 16, 2018 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01732913 live on ClinicalTrials.gov.