Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Public ClinicalTrials.gov record NCT01732926. 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 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 addition of idelalisib to bendamustine/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
- NCT01732926
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 475 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 1, 2013
- Primary completion
- May 16, 2016
- Completion
- May 16, 2016
- Last update posted
- Nov 15, 2018
2013 – 2016
United States locations
- U.S. sites
- 33
- U.S. states
- 14
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| Ironwood Cancer and Research Center | Chandler | Arizona | 85224 | — |
| Comprehensive Blood and Cancer Center (Bakersfield) | Bakersfield | California | 93309 | — |
| Saint Jude Heritage Healthcare (TORI) | Fullerton | California | 92835 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| Cancer Care Associates | Redondo Beach | California | 90277 | — |
| San Luis Obispo Oncology and Hematology | San Luis Obispo | California | 93401 | — |
| Cancer Center of Santa Barbara | Santa Barbara | California | 93105 | — |
| Central Coast Medical Oncology Group | Santa Maria | California | 93454 | — |
| St Joseph Heritage Healthcare System | Santa Rosa | California | 95403 | — |
| Kaiser Permanente Vallejo Medical Center | Vallejo | California | 94589 | — |
| Sylvester Comprehensive Cancer Center/UMHC | Deerfield Beach | Florida | 33442 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Joliet Oncology Hematology Associates Ltd. | Joliet | Illinois | 60435 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| North Shore Hematology/Oncology Associates | East Setauket | New York | 11733 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | — |
| Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Bon Secours Saint Francis Hospital | Greenville | South Carolina | 29607 | — |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | — |
| Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology, P.A. | Denton | Texas | 76210 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Texas Oncology, P.A. | Harlingen | Texas | 78550-8321 | — |
| Texas Oncology, P.A. | Weslaco | Texas | 78596-6608 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| Northwest Medical Specialists | Tacoma | Washington | 98405 | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54308 | — |
| 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 111 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01732926, 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 15, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01732926 live on ClinicalTrials.gov.