A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT01539512
Last Updated: 2019-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2012-04-30
2014-04-30
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
TRIPLE
Study Groups
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Idelalisib + rituximab
Participants will receive idelalisib plus rituximab
Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter
Placebo + rituximab
Participants will receive placebo to match idelalisib plus rituximab
Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter
Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily
Interventions
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Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter
Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Jahn, MD
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 Medical Research Corporation
Boynton Beach, Florida, United States
Collaborative Research Group LLC
Boynton Beach, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Florida
Gainesville, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey
Morristown, 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 Cancer Center
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
Hôpital Henri Mondor
Créteil, , France
Centre Hospitalier Régional Universitaire de Lille (CHRU)
Lille, , France
Hôpital Emile Muller
Mulhouse, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Hopital Purpan
Toulouse, , France
Universitätsklinikum Köln
Cologne, , Germany
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, , Germany
Internistische Gemeinschaftspraxis
Erlangen, , Germany
Stauferklinikum Schwäb. Gmünd
Mutlangen, , Germany
Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
Neunkirchen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Ospedale Oncologico Regionale A. Businco
Cagliari, , Italy
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
University Hospital of Wales
Cardiff, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
King's College Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Princess Royal University Hospital
Orpington, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Torbay District General Hospital
Torquay, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Yeovil District Hospital
Yeovil, , United Kingdom
Countries
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References
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Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.
Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.
Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.
Other Identifiers
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2011-005180-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-312-0116
Identifier Type: -
Identifier Source: org_study_id
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