A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Last updated: May 1, 2019
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Platelet Disorders

Treatment

Idelalisib

Rituximab

Placebo to match idelalisib

Clinical Study ID

NCT01539512
GS-US-312-0116
2011-005180-24
  • Ages > 18
  • All Genders

Study Summary

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Eligibility Criteria

Inclusion

Inclusion:

  • Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy

  • Require therapy for CLL

  • Have experienced CLL progression < 24 months since the completion of the last prior therapy

  • Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.

Study Design

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: Idelalisib
Phase: 3
Study Start date:
April 01, 2012
Estimated Completion Date:
April 30, 2014

Connect with a study center

  • Hôpital Henri Mondor

    Creteil, 94010
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Lille (CHRU)

    Lille, 59045
    France

    Site Not Available

  • Hôpital Emile Muller

    Mulhouse, 68100
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Hôpital Pontchaillou

    Rennes, 35019
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Hopital Purpan

    Toulouse, 31059
    France

    Site Not Available

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 1307
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis

    Erlangen, 91052
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Stauferklinikum Schwäb. Gmünd

    Mutlangen, 73557
    Germany

    Site Not Available

  • Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth

    Neunkirchen, 66538
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Ospedale Oncologico Regionale A. Businco

    Cagliari, 9121
    Italy

    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

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Castle Hill Hospital

    Cottingham, HU10 6ED
    United Kingdom

    Site Not Available

  • Dorset County Hospital

    Dorchester, DT1 2JY
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    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

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Princess Royal University Hospital

    Orpington, BR6 8ND
    United Kingdom

    Site Not Available

  • Salisbury District Hospital

    Salisbury, SP2 8BJ
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Great Western Hospital

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Torbay District General Hospital

    Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Yeovil District Hospital

    Yeovil, BA21 4AT
    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 20057
    United States

    Site Not Available

  • Collaborative Medical Research Corporation

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Collaborative Research Group LLC

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Florida Cancer Specialists

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida

    Gainsville, Florida 32610
    United States

    Site Not Available

  • Florida Cancer Specialists

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Florida Cancer Specialists

    St. Petersburg, Florida 33705
    United States

    Site Not Available

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia 30322
    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

  • Hematology Oncology Associates of Northern New Jersey

    Morristown, New Jersey 07962
    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 Cancer Center

    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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