Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539291
Recruitment Status : Active, not recruiting
First Posted : February 27, 2012
Last Update Posted : May 8, 2018
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension study that is a companion study to Study GS-US-312-0116, to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Idelalisib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia
Actual Study Start Date : October 3, 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Active Comparator: High-dose Idelalisib
Participants will receive idelalisib 300 mg twice daily (600 mg per day).
Drug: Idelalisib
Idelalisib 150 mg tablet(s) administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL 101
Active Comparator: Standard-dose Idelalisib
Participants will receive idelalisib 150 mg twice daily (300 mg per day)
Drug: Idelalisib
Idelalisib 150 mg tablet(s) administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL 101

Primary Outcome Measures :
  1. Overall Safety [ Time Frame: Baseline to Month 12 ]
    Overall safety profile of each study treatment regimen will be characterized by the type, frequency, severity, timing of onset, duration, and relationship to study therapy of any adverse events or abnormalities of laboratory tests, serious adverse events, or adverse events leading to discontinuation of study drug.

Secondary Outcome Measures :
  1. Tumor Control [ Time Frame: Baseline to Month 12 ]
    Tumor control will be assessed by progression-free survival, overall response rate, lymph node response rate, complete response rate, time to response, duration of response, percent change in lymph node area, splenomegaly response rate, hepatomegaly response rate, absolute lymphocyte count (ALC) response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate.

  2. Patient Well-Being [ Time Frame: Baseline to Month 12 ]
    Patient well-being will be assessed by overall survival, change from baseline in health-related quality of life (HRQL) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Leukemia (FACT-Leu), and changes from baseline in Karnofsky performance status.

  3. Pharmacodynamic [ Time Frame: Baseline to Month 6 ]
    Pharmacodynamics will be assessed by changes from baseline in phosphatidylinositol 3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway activation and changes from baseline in the plasma concentrations of disease-associated chemokines and cytokines.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
  • Tolerating primary study therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01539291

  Hide Study Locations
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85704
United States, California
University of California, San Diego - Moores Cancer Center
La Jolla, California, United States, 92093
Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
Santa Monica, California, United States, 90404
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Collaborative Research Group
Boynton Beach, Florida, United States, 33435
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11042
Weill Cornell Medical College
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oregon
Willamette Valley Cancer Center
Springfield, Oregon, United States, 97477
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States, 97062
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Care Network of South Texas
San Antonio, Texas, United States, 78217
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1024
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Henri Becquerel
Rouen, France, 76038
Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker
Erlangen, Germany, 91052
Universitätsklinikum Köln
Köln, Germany, 50937
Ospedale San Raffaele S.r.l.
Milano, Italy, 20132
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Dorset County Hospital
Dorchester, United Kingdom, DT1 2JY
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Hammersmith Hospital
London, United Kingdom, W12 0NN
Princess Royal University Hospital
Orpington, United Kingdom, BR6 8ND
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Gilead Sciences
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences Identifier: NCT01539291     History of Changes
Other Study ID Numbers: GS-US-312-0117
2011-006293-72 ( EudraCT Number )
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
CAL 101
GS 1101

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action