A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
2 other identifiers
interventional
220
5 countries
72
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2012
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
October 16, 2014
CompletedMay 14, 2019
April 1, 2015
1.5 years
February 12, 2012
October 9, 2014
May 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Up to 17 months
Secondary Outcomes (4)
Overall Response Rate
Up to 17 months
Lymph Node Response Rate
Up to 17 months
Overall Survival
Up to 17 months
Complete Response Rate
Up to 17 months
Study Arms (2)
Idelalisib + rituximab
ACTIVE COMPARATORParticipants will receive idelalisib plus rituximab
Placebo + rituximab
PLACEBO COMPARATORParticipants will receive placebo to match idelalisib plus rituximab
Interventions
Idelalisib 150 mg tablet administered orally twice daily
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter
Placebo to match idelalisib administered orally twice daily
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (72)
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 D.C., District of Columbia, 20057, United States
Collaborative Medical Research Corporation
Boynton Beach, Florida, 33435, United States
Collaborative Research Group LLC
Boynton Beach, Florida, 33435, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
University of Florida
Gainesville, 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
Weill Cornell Medical College
New York, New York, 10021, 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
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
Hôpital Henri Mondor
Créteil, 94010, France
Centre Hospitalier Régional Universitaire de Lille (CHRU)
Lille, 59045, France
Hôpital Emile Muller
Mulhouse, 68100, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hôpital Pontchaillou
Rennes, 35019, France
Centre Henri Becquerel
Rouen, 76038, France
Hopital Purpan
Toulouse, 31059, France
Universitätsklinikum Köln
Cologne, 50937, Germany
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 1307, Germany
Internistische Gemeinschaftspraxis
Erlangen, 91052, Germany
Stauferklinikum Schwäb. Gmünd
Mutlangen, 73557, Germany
Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
Neunkirchen, 66538, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Ospedale Oncologico Regionale A. Businco
Cagliari, 9121, Italy
Ospedale San Raffaele S.r.l.
Milan, 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
University Hospital of Wales
Cardiff, CF14 4XW, 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
King's College Hospital
London, SE5 9RS, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
Freeman Hospital
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
Royal Marsden Hospital
Sutton, SM2 5PT, 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
Related Publications (3)
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.
PMID: 33297794DERIVEDGordon 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.
PMID: 32599655DERIVEDFurman 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.
PMID: 24450857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Following a recommendation by an independent Data Monitoring Committee (DMC), the study was stopped early due to highly statistically significant results for the primary efficacy endpoint of progression-free survival.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Thomas Jahn, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2012
First Posted
February 27, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2013
Study Completion
April 1, 2014
Last Updated
May 14, 2019
Results First Posted
October 16, 2014
Record last verified: 2015-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.