Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

Last updated: August 12, 2019
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

3

Condition

Platelet Disorders

Lymphocytic Leukemia, Chronic

Leukemia

Treatment

Idelalisib

Clinical Study ID

NCT01539291
GS-US-312-0117
2011-006293-72
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 161
Treatment Group(s): 1
Primary Treatment: Idelalisib
Phase: 3
Study Start date:
October 03, 2012
Estimated Completion Date:
June 29, 2018

Connect with a study center

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker

    Erlangen, 91052
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Ospedale San Raffaele S.r.l.

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Dorset County Hospital

    Dorchester, DT1 2JY
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • St James's University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, W12 0NN
    United Kingdom

    Site Not Available

  • Princess Royal University Hospital

    Orpington, BR6 8ND
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Clearview Cancer Institute

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Arizona Oncology Associates

    Tucson, Arizona 85704
    United States

    Site Not Available

  • University of California, San Diego - Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Ventura County Hematology Oncology Specialists

    Oxnard, California 93030
    United States

    Site Not Available

  • UCLA

    Santa Monica, California 90404
    United States

    Site Not Available

  • Stanford Cancer Center

    Stanford, California 94305
    United States

    Site Not Available

  • Rocky Mountain Blood and Marrow Transplant Program

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Georgetown University Medical Center Lombardi Cancer Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Collaborative Research Group

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Florida Cancer Specialists

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Florida Cancer Specialists

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Site Not Available

  • Willamette Valley Cancer Center

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Northwest Cancer Specialists, PC

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Cancer Centers of the Carolinas

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology, P.A.

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Cancer Care Network of South Texas

    San Antonio, Texas 78217
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109-1024
    United States

    Site Not Available

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington 98902
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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