Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
2 other identifiers
interventional
261
11 countries
80
Brief Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2012
Longer than P75 for phase_3
80 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
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
December 4, 2012
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2018
CompletedAugust 14, 2019
August 1, 2019
5.7 years
August 3, 2012
February 14, 2017
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
Progression-free survival (PFS) 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. PFS was analyzed using Kaplan-Meier (KM) estimates.
Randomization to End of Study (up to 60 months)
Secondary Outcomes (5)
Overall Response Rate
Randomization to End of Study (up to 60 months)
Lymph Node Response Rate
Randomization to End of Study (up to 60 months)
Overall Survival
Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Randomization to End of Study (up to 60 months)
Complete Response Rate
Randomization to End of Study (up to 60 months)
Study Arms (2)
Idelalisib+ofatumumab
EXPERIMENTALRandomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Ofatumumab
ACTIVE COMPARATORRandomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Interventions
150 mg tablets administered orally twice daily
Eligibility Criteria
You may qualify if:
- Adults 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
- Have disease that is not refractory to ofatumumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (80)
City of Hope
Duarte, California, 91010, United States
California Cancer Associates for Research and Excellence (CCARE)
Fresno, California, 93720, United States
Kaiser Permanente
San Diego, California, 92120, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Kaiser Permanente Vallejo Medical Center
Vallejo, California, 94589, United States
Kaiser Permanente of Colorado
Denver, Colorado, 80205, United States
Saint Mary's Regional Cancer Center
Grand Junction, Colorado, 81501, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353, United States
Center for Cancer and Blood Disorders, PC
Bethesda, Maryland, 20817, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University Medical Center
St Louis, Missouri, 63110-1010, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
The Ohio State University Medical Center
Columbus, Ohio, 43202, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Upstate Oncology Associates
Greenville, South Carolina, 29601, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404, United States
Tenessee Oncology, PLLC
Nashville, Tennessee, 37203-1781, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Saint George and Sutherland Hospitals
Kogarah, New South Wales, 2217, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Haematology and Oncology Clinics of Australia at Mater
Milton, Queensland, 4064, Australia
Ashford Cancer Centre Research
Ashford, South Australia, 5035, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Frankston Hospital
Melbourne, Victoria, 3199, Australia
Queen Elizabeth Hospital
Woodville, 5011, Australia
Ziekenhuis Netwerk Antwerpen
Antwerp, 2060, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuis Gasthuisberg
Leuven, 3000, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 2T9, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
Greater Sudbury, Ontario, P3E 5J1, Canada
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1, Canada
Saskatchewan Cancer Agency
Regina, Saskatchewan, S4T 1A5, Canada
Cancer Care Manitoba
Winnipeg, R3E 0V9, Canada
Aalborg Hospital
Aalborg, 9100, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Center Hospitalier Universitaire de Bordeaux
Pessac, Aquitaine, 33604, France
Centre Hospitalier de Perpignan
Perpignan, Languedoc-Roussillon, 66046, France
Centre Hospitalier Universitaire Nancy
Vandœuvre-lès-Nancy, Limousin, Lorraine, 54511, France
Centre Hospitalier Universitaire Purpan
Toulouse, Midi-pyrenees, 31059, France
CHRU Clermont- Ferrand CHU Estaing
Auvergne, 63000, France
Centre Hospitalier Universitaire Hôpital Avicenne
Ile-de-france, 93009, France
Hôpital Saint Louis
Paris, Île-de-France Region, 75010, France
University College Cork
Cork, Ireland
Saint James's Hospital
Dublin, 8, Ireland
Collegium Medicum Uniwersytetu Jagiellonskiego w K
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Kor
Słupsk, Pomeranian Voivodeship, 76-200, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, 36-200, Poland
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
Lódz, 93-510, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Samodzielny Publiczny Szpital Kliniczny N1 Klinika
Wroclaw, 50-367, Poland
Hospital Clínic i Provincial
Barcelona, 08025, Spain
Hospital Vall d´Hebrón
Barcelona, 08035, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Puerta de Hierro Majadahonda
Madrid, 28222, Spain
Hospital Morales Meseguer
Murcia, 30008, Spain
Sunderby Sjukhus
Luleå, 971 80, Sweden
Karolinska University Hospital Solna
Stockholm, 171 64, Sweden
Karolinska University Hospital Huddinge
Stockholm, 171 76, Sweden
Birmingham Heartlands Hospital
Birmingham, England, B9 5ST, United Kingdom
Darent Valley Hospital
Dartford, England, DA2 8DA, United Kingdom
Royal Surrey County Hospital NHS Trust
Guildford, England, GU2 7XX, United Kingdom
Haematology and Transplant Unit
Manchester, England, M20 4BX, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Saint James's University Hospital
Leeds, LS9 7TF, United Kingdom
University College London
London, NW1 2PG, United Kingdom
University College London
London, WC1E 6BT, United Kingdom
Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
Oxford, OX3 7LE, United Kingdom
Related Publications (7)
Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.
PMID: 28257752RESULTJones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.
RESULTJones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.
RESULTRobak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.
RESULTRobak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.
RESULTFlinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.
RESULTGordon 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: 32599655DERIVED
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 7, 2012
Study Start
December 4, 2012
Primary Completion
August 15, 2018
Study Completion
August 15, 2018
Last Updated
August 14, 2019
Results First Posted
March 31, 2017
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.