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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia

Intervention: Idelalisib (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Theo Brandt-Sarif, MD, Study Director, Affiliation: Gilead Sciences

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Overall Safety

Secondary outcome:

Tumor Control

Patient Well-Being

Pharmacodynamic

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion:

- Subjects in the primary Phase 3 study (Study GS-US-312-0116) who are compliant

- Tolerating primary study therapy

Locations and Contacts

Hôpital Henri Mondor, Creteil 94010, France

CHRU Lille, Lille 59045, France

Centre Hospitalier Lyon Sud, Pierre Benite 69495, France

Hôpital Pontchaillou, Rennes 35019, France

Centre Henri Becquerel, Rouen 76038, France

Hopital Purpan, Toulouse 31059, France

Gemeinschaftspraxis Hämatologie-Onkologie, Dresden 1307, Germany

Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker, Erlangen 91052, Germany

Universitätsklinikum Köln, Köln 50937, Germany

Universitätsklinikum Ulm, Ulm 89081, Germany

Ospedale Oncologico Regionale A. Businco, Cagliari 9121, Italy

Ospedale San Raffaele S.r.l., Milano 20132, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino 10126, Italy

Royal Bournemouth Hospital, Bournemouth BH7 7DW, United Kingdom

Addenbrooke's Hospital, Cambridge CB2 0QQ, United Kingdom

Castle Hill Hospital, Cottingham HU10 6ED, United Kingdom

Dorset County Hospital, Dorchester DT1 2JY, United Kingdom

Western General Hospital, Edinburgh EH4 2XU, United Kingdom

Northwick Park Hospital, Harrow HA1 3UJ, United Kingdom

St James's University Hospital, Leeds LS9 7TF, United Kingdom

Royal Liverpool University Hospital, Liverpool L7 8XP, United Kingdom

Hammersmith Hospital, London W12 0NN, United Kingdom

King's College Hospital, London SE5 9RS, United Kingdom

Sarah Cannon Research Institute UK, London W1G 6AD, United Kingdom

Freeman Hospital Northern Centre for Cancer Care, Newcastle upon Tyne NE7 7DN, United Kingdom

Princess Royal University Hospital, Orpington BR6 8ND, United Kingdom

Salisbury District Hospital, Salisbury SP2 8BJ, United Kingdom

Southampton General Hospital, Southampton SO16 6YD, United Kingdom

Great Western Hospital, Swindon SN3 6BB, United Kingdom

Torbay District General Hospital, Torquay TQ2 7AA, United Kingdom

Royal Cornwall Hospital, Truro TR1 3LJ, United Kingdom

New Cross Hospital, Wolverhampton WV10 0QP, United Kingdom

Yeovil District Hospital, Yeovil BA21 4AT, United Kingdom

Clearview Cancer Institute, Huntsville, Alabama 35805, United States

Arizona Oncology Associates, Tucson, Arizona 85704, United States

University of California, San Diego - Moores Cancer Center, La Jolla, California 92093, United States

Ventura County Hematology Oncology Specialists, Oxnard, California 93030, United States

UCLA, Santa Monica, California 90404, United States

Stanford Cancer Center, Stanford, California 94305, United States

Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado 80218, United States

Rocky Mountain Cancer Center, Denver, Colorado 80218, United States

Georgetown University Medical Center Lombardi Cancer Center, Washington, District of Columbia 20007, United States

Collaborative Research Group, Boynton Beach, Florida 33435, United States

Florida Cancer Specialists, Fort Myers, Florida 33916, United States

University of Florida, Gainsville, Florida 32610, United States

Florida Cancer Specialists, St. Petersburg, Florida 33705, United States

Winship Cancer Institute at Emory University, Atlanta, Georgia 30322, United States

Northwestern University, Chicago, Illinois 60611, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Hematology Oncology Associates of Northern New Jersey, Morristown, New Jersey 07962, United States

Long Island Jewish Medical Center, New Hyde Park, New York 11042, United States

Columbia University Medical Center, New York, New York 10032, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States

Weill Cornell Medical College, New York, New York 10021, United States

Willamette Valley Cancer Center, Springfield, Oregon 97477, United States

Northwest Cancer Specialists, PC, Tualatin, Oregon 97062, United States

Cancer Centers of the Carolinas, Greenville, South Carolina 29605, United States

Sarah Cannon Cancer Center, Nashville, Tennessee 37203, United States

Texas Oncology, P.A., Fort Worth, Texas 76104, United States

M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Cancer Care Network of South Texas, San Antonio, Texas 78217, United States

Virginia Cancer Specialists, PC, Fairfax, Virginia 22031, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States

Seattle Cancer Care Alliance, Seattle, Washington 98109-1024, United States

Yakima Valley Memorial Hospital/North Star Lodge, Yakima, Washington 98902, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: October 2012
Last updated: June 8, 2015

Page last updated: August 23, 2015

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