Clinical trial NCT01569295: Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Keywords: Zydelig
CLL
CAL-101
GS 1101
GS-1101
PI3K
Rituxan
Rituximab
Bendamustine
Leukemia
idelalisib
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Key Inclusion Criteria:

* Previously treated recurrent CLL
* Measurable lymphadenopathy
* Requires therapy for CLL
* Has experienced CLL progression \< 36 months since the completion of the last prior therapy

Key Exclusion Criteria:

* Recent history of a major non-CLL malignancy
* Evidence of an ongoing infection
* CLL refractory to bendamustine
* Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 84 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 84 months
measure: Lymph Node Response Rate
timeFrame: Up to 84 months
measure: Overall Survival
timeFrame: Up to 84 months
measure: Complete Response Rate
timeFrame: Up to 84 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute at Emory University
state: Georgia
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Morristown
country: United States
facility: Summit Medical Group, P.A.
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology PA
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest, US Oncology
state: Washington
city: Vancouver
country: United States
facility: Virginia Cancer Specialists, PC
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital - Sydney
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre - Clayton Campus
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Antwerpen
country: Belgium
facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Zagreb
country: Croatia
facility: Clinical Hospital "Dubrava"
city: Zagreb
country: Croatia
facility: Klinichki Bolnicki Centar-Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Merkur
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Le Mans cedex
country: France
facility: Centre Jean Bernard - Clinique Victor Hugo
city: Lille
country: France
facility: CHRU Lille-Hôpital Claude Huriez
city: Lyon
country: France
facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Nantes
country: France
facility: CHU Hôtel-Dieu-Service Hématologie
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Toulouse
country: France
facility: Hopital Purpan
city: Vandoeuvre-lés-Nancy
country: France
facility: Hôpitaux de Brabois
city: Athens
country: Greece
facility: G. Genimatas Hospital
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum
city: Kaposvár
country: Hungary
facility: Tallian Gyula utca 20-32
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ospedale Oncologico Regionale A. Businco
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Opole
country: Poland
facility: Wojewodzki Szpital w Opolu
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Porto
country: Portugal
facility: "Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
city: Brasov
country: Romania
facility: Emergency County Clinical Hospital Brasov
city: Bucharest
country: Romania
facility: "Colentina" Clinical Hospital
city: Bucharest
country: Romania
facility: "Fundeni" Clinical Institute
city: Iasi
country: Romania
facility: Regional Oncology Institute Iasi
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center (N.N. Blokhin)
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Hematology and Blood Transfusion
city: Volgograd
country: Russian Federation
facility: State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
state: Madrid, Communidad De
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid, Communidad De
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Gazi Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Faculty of Medicine
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: University College London
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Barrientos 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.
citation: Hillmen, 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.
citation: Zelenetz 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
citation: Zelenetz 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.
citation: Montillo 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.