Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Public ClinicalTrials.gov record NCT01980888. 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 in Combination With Bendamustine and Rituximab for Previously Untreated 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 progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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
- NCT01980888
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 311 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
- Feb 5, 2014 (Actual)
- Primary completion
- May 30, 2016 (Actual)
- Completion
- Jun 16, 2016 (Actual)
- Last update posted
- Nov 19, 2018
2014 – 2016
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center | Fullerton | California | 92835 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | — |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| Florida Cancer Specialists-South | Sarasota | Florida | 34236 | — |
| Franciscan Physician Network Oncology & Hematology | Indianapolis | Indiana | 46237 | — |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89074 | — |
| Hematology /Oncology Associates of Northern New Jersey | Morristown | New Jersey | 07962 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Sarah Cannon Research Institute | Cincinnati | Ohio | 45242 | — |
| Signal Point Clinical Research Center | Middletown | Ohio | 45042 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84103 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
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 68 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01980888, 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 19, 2018 · 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 NCT01980888 live on ClinicalTrials.gov.