Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
NCT ID: NCT01539291
Last Updated: 2019-08-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
161 participants
INTERVENTIONAL
2012-10-03
2018-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High-dose Idelalisib
Participants will receive idelalisib 300 mg twice daily (600 mg per day).
Idelalisib
Idelalisib tablet(s) administered orally twice daily
Standard-dose Idelalisib
Participants will receive idelalisib 150 mg twice daily (300 mg per day)
Idelalisib
Idelalisib tablet(s) administered orally twice daily
Interventions
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Idelalisib
Idelalisib tablet(s) administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tolerating primary study therapy
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Oncology Associates
Tucson, Arizona, United States
University of California, San Diego - Moores Cancer Center
La Jolla, California, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
UCLA
Santa Monica, California, United States
Stanford Cancer Center
Stanford, California, United States
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Collaborative Research Group
Boynton Beach, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Northwestern University
Chicago, Illinois, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Weill Cornell Medical College
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Willamette Valley Cancer Center
Springfield, Oregon, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Cancer Care Network of South Texas
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Universitätsklinikum Köln
Cologne, , Germany
Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker
Erlangen, , Germany
Ospedale San Raffaele S.r.l.
Milan, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Princess Royal University Hospital
Orpington, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Coutre SE, Furman RR, Sharman, JP, Cheson BD, Pagel JM, Hillmen P, et al. Second Interim Analysis of a Phase 3 Study of Idelalisib (Zydelig®) Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia: Efficacy Analysis in Patient Subpopulations with Del(17p) and Other Adverse Prognostic Factors. Blood 2014; 124 (21):330
Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, et al. Efficacy of Idelalisib in CLL Subpopulations Harboring Del(17p) and Other Adverse Prognostic Factors: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial [Poster 7011]. American Society of Clinical Oncology (ASCO) 50th Annual Meeting; 2014 May 30-June 3; Chicago, IL. J Clin Oncol 32:5s, 2014 (suppl; abstr 7011)
Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn IW, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Tausch E, Cramer P, Huang J, Mitra S, Hallek M, O'Brien SM, Stilgenbauer S. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J Clin Oncol. 2019 Jun 1;37(16):1391-1402. doi: 10.1200/JCO.18.01460. Epub 2019 Apr 17.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Study Protocol: Amendment 5
Document Type: Study Protocol: Amendment 6
Document Type: Study Protocol: Amendment 7
Document Type: Statistical Analysis Plan: Blinded
Document Type: Statistical Analysis Plan: Open Label
Document Type: Study Protocol: Amendment 8
Document Type: Study Protocol: Amendment 9
Other Identifiers
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2011-006293-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-312-0117
Identifier Type: -
Identifier Source: org_study_id
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