Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
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 A Companion Trial to Study GS-US-312-0116: 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
161
5 countries
45
Brief Summary
The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.
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 Oct 2012
Longer than P75 for phase_3
45 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
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2018
CompletedResults Posted
Study results publicly available
August 20, 2019
CompletedAugust 20, 2019
August 1, 2019
5.6 years
February 12, 2012
May 9, 2019
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
PFS was defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria other than lymphocytosis alone. PFS was analyzed using Kaplan-Meier (KM) estimates.
GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation
The TEAEs were defined as events in a given study period that met one of the following criteria: * Events with onset dates on or after the start of treatment and up to 30 days after the permanent discontinuation of the study treatment. * The continuing adverse events (AEs) diagnosed prior to the start of treatment and worsened in severity grade, or non-serious AEs at baseline which became serious, or AEs resulting in treatment discontinuation after the start of treatment. The severity of AEs was graded by the investigator according to the common terminology criteria for adverse events (CTCAE), Version 4.03, whenever possible. The relationship of an AE to study drug (idelalisib) was assessed using clinical judgment by the investigator, describing the event as either unrelated or related. Events for which the investigator did not record relationship to study drug were considered related to study drug.
First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months) plus 4 weeks
Secondary Outcomes (20)
Overall Response Rate (ORR)
GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
Lymph Node Response Rate
GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
Complete Response (CR) Rate
GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
Time to Response (TTR)
GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
Duration of Response (DOR)
From first documentation of CR or PR to end of study GS-US-312-0117 (maximum: up to 67.6 months)
- +15 more secondary outcomes
Study Arms (2)
High-dose Idelalisib
EXPERIMENTALParticipants will receive idelalisib 300 mg twice daily (600 mg per day).
Standard-dose Idelalisib
EXPERIMENTALParticipants will receive idelalisib 150 mg twice daily (300 mg per day)
Interventions
Idelalisib tablet(s) administered orally twice daily
Eligibility Criteria
You may qualify if:
- Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
- Tolerating primary study therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (45)
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, 20007, United States
Collaborative Research Group
Boynton Beach, Florida, 33435, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Northwestern University
Chicago, Illinois, 60611, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, 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 Research Institute
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
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Henri Becquerel
Rouen, 76038, France
Universitätsklinikum Köln
Cologne, 50937, Germany
Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker
Erlangen, 91052, Germany
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
Dorset County Hospital
Dorchester, DT1 2JY, 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
Princess Royal University Hospital
Orpington, BR6 8ND, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (3)
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
RESULTSharman 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)
RESULTSharman 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.
PMID: 30995176RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
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
- DOUBLE
- Who Masked
- PARTICIPANT, 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
October 3, 2012
Primary Completion
May 21, 2018
Study Completion
June 29, 2018
Last Updated
August 20, 2019
Results First Posted
August 20, 2019
Record last verified: 2019-08
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.