Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Tugela
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
2 other identifiers
interventional
416
18 countries
106
Brief Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) 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 Jun 2012
Longer than P75 for phase_3
106 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
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedStudy Start
First participant enrolled
June 15, 2012
CompletedResults Posted
Study results publicly available
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2019
CompletedMarch 10, 2020
March 1, 2020
7 years
March 27, 2012
December 18, 2017
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Up to 84 months
Secondary Outcomes (4)
Overall Response Rate (ORR)
Up to 84 months
Lymph Node Response Rate
Up to 84 months
Overall Survival
Up to 84 months
Complete Response Rate
Up to 84 months
Study Arms (2)
Idelalisib+bendamustine+rituximab
EXPERIMENTALParticipants will receive idelalisib plus bendamustine and rituximab
Placebo to match idelalisib+bendamustine+rituximab
PLACEBO COMPARATORParticipants will receive placebo to match idelalisib plus bendamustine and rituximab
Interventions
Idelalisib 150 mg administered orally twice daily
Rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a maximum of 6 infusions
Bendamustine 70 mg/mg\^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Placebo to match idelalisib administered orally twice daily
Eligibility Criteria
You may qualify if:
- Previously treated recurrent CLL
- Measurable lymphadenopathy
- Requires therapy for CLL
- Has experienced CLL progression \< 36 months since the completion of the last prior therapy
You may not qualify if:
- Recent history of a major non-CLL malignancy
- Evidence of an ongoing infection
- CLL refractory to bendamustine
- Concurrent participation in another therapeutic clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (106)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Stanford Cancer Center
Palo Alto, California, 94035, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
University of Florida
Gainesville, Florida, 32603, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Summit Medical Group, P.A.
Morristown, New Jersey, 07962, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97477, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29414, United States
Texas Oncology
Austin, Texas, 78731, United States
Texas Oncology PA
Dallas, Texas, 75246, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Cancer Care Northwest, US Oncology
Spokane, Washington, 99202, United States
Virginia Cancer Specialists, PC
Vancouver, Washington, 98684, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
St Vincent's Hospital - Sydney
Darlinghurst, New South Wales, 2010, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Centre - Clayton Campus
Clayton, Victoria, 3168, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
Antwerp, 2060, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Clinical Hospital "Dubrava"
Zagreb, 10000, Croatia
Klinichki Bolnicki Centar-Zagreb
Zagreb, 10000, Croatia
University Hospital Merkur
Zagreb, 10000, Croatia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultní nemocnice Hradec Králové
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 52, Czechia
Hopital Henri Mondor
Créteil, 94010, France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72015, France
CHRU Lille-Hôpital Claude Huriez
Lille, 59045, France
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon, 69373, France
Centre Hospitalier de Mulhouse
Mulhouse, 68100, France
CHU Hôtel-Dieu-Service Hématologie
Nantes, 44 093, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Pierre Bénite, France
Hopital Purpan
Toulouse, 31059, France
Hôpitaux de Brabois
Vandoeuvre-lés-Nancy, 54511, France
G. Genimatas Hospital
Athens, 11527, Greece
University General Hospital of Patras
Pátrai, 26500, Greece
Semmelweis Egyetem
Budapest, 1083, Hungary
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, 4032, Hungary
Tallian Gyula utca 20-32
Kaposvár, 7400, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6720, Hungary
Mater Misericordiae Hospital
Dublin, Ireland
Spedali Civili di Brescia
Brescia, 25123, Italy
Ospedale Oncologico Regionale A. Businco
Cagliari, 9121, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette
Torino, 10126, Italy
Szpital Specjalistyczny w Brzozowie
Brzozów, 36-200, Poland
Malopolskie Centrum Medyczne
Krakow, 30-510, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-510, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081, Poland
Wojewodzki Szpital w Opolu
Opole, 43-372, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Hospital Santa Maria
Lisbon, 1649-035, Portugal
"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
Porto, 4200-072, Portugal
Emergency County Clinical Hospital Brasov
Brasov, 500152, Romania
"Colentina" Clinical Hospital
Bucharest, 20125, Romania
"Fundeni" Clinical Institute
Bucharest, 22328, Romania
Regional Oncology Institute Iasi
Iași, 700483, Romania
Russian Oncology Research Center (N.N. Blokhin)
Moscow, 115478, Russia
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, 603126, Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390039, Russia
Research Institute of Hematology and Blood Transfusion
Saint Petersburg, 193024, Russia
Saratov State Medical University
Saratov, 410028, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1
Volgograd, 400138, Russia
Hospital Universitario Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, 8036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 8041, Spain
Hospital 12 de Octubre
Madrid, Madrid, Communidad de, 28041, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Communidad de, 28222, Spain
Hospital Universitario de La Princesa
Madrid, 28033, Spain
Gazi University Medical Faculty Gazi Hospital
Ankara, 06500, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 6590, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Ondokuz Mayis University Faculty of Medicine
Samsun, 55239, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
St. James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
University College London
London, WC1E 6BT, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (6)
Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.
BACKGROUNDBarrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.
BACKGROUNDHillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.
BACKGROUNDZelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA
BACKGROUNDZelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illes A, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.
PMID: 28139405BACKGROUNDMontillo M, Illes A, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.
PMID: 31729982DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
April 3, 2012
Study Start
June 15, 2012
Primary Completion
June 10, 2019
Study Completion
June 10, 2019
Last Updated
March 10, 2020
Results First Posted
February 27, 2018
Record last verified: 2020-03
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.