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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 Oct 19, 2026, 11:17 AM 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 4, 2012 (Actual)
Primary completion
Aug 15, 2018 (Actual)
Completion
Aug 15, 2018 (Actual)
Last update posted
Aug 14, 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 14, 2019 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01659021 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →