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Terminated Phase 3 Interventional Results available

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

ClinicalTrials.gov ID: NCT01659021

Public ClinicalTrials.gov record NCT01659021. 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.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:29 PM EDT

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, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated 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 effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

Study identification

NCT ID
NCT01659021
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
261 participants

Conditions and interventions

Interventions

Drug

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
Dec 3, 2012
Primary completion
Aug 14, 2018
Completion
Aug 14, 2018
Last update posted
Aug 13, 2019

2012 – 2018

United States locations

U.S. sites
24
U.S. states
16
U.S. cities
24
Facility City State ZIP Site status
City of Hope Duarte California 91010
California Cancer Associates for Research and Excellence (CCARE) Fresno California 93720
Kaiser Permanente San Diego California 92120
Coastal Integrative Cancer Care San Luis Obispo California 93401
Stanford University Medical Center Stanford California 94305
Kaiser Permanente Vallejo Medical Center Vallejo California 94589
Kaiser Permanente of Colorado Denver Colorado 80205
Saint Mary's Regional Cancer Center Grand Junction Colorado 81501
Cancer Specialists of North Florida Jacksonville Florida 32256
Georgia Regents University Augusta Georgia 30912
Montgomery Cancer Center Mount Sterling Kentucky 40353
Center for Cancer and Blood Disorders, PC Bethesda Maryland 20817
Dana Farber Cancer Institute Boston Massachusetts 02215
Washington University Medical Center St Louis Missouri 63110-1010
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169
Weill Cornell Medical Center New York New York 10065
Oncology Hematology Care, Inc. Cincinnati Ohio 45242
The Ohio State University Medical Center Columbus Ohio 43202
Oregon Health and Science University Portland Oregon 97239
Upstate Oncology Associates Greenville South Carolina 29601
Tennessee Oncology, PLLC Chattanooga Tennessee 37404
Tenessee Oncology, PLLC Nashville Tennessee 37203-1781
Utah Cancer Specialists Salt Lake City Utah 84106
Northwest Medical Specialties Tacoma Washington 98405

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 56 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01659021, 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 13, 2019 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01659021 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →