Clinical trial NCT01980888: Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 311
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 progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).


Eligibility criteria: Key Inclusion Criteria:

* Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
* No prior therapy for CLL other than corticosteroids for disease complications
* CLL that warrants treatment
* Presence of measurable lymphadenopathy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

* Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
* Known presence of myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
* Ongoing liver injury
* History of non-infectious pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization

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

Primary outcomes:
measure: Progression-Free Survival
timeFrame: Up to 22 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 22 months
measure: Nodal Response Rate
timeFrame: Up to 22 months
measure: Complete Response Rate
timeFrame: Up to 22 months
measure: Overall Survival
timeFrame: Up to 22 months
measure: Minimal Residual Disease Negativity Rate at Week 36
timeFrame: Up to 22 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists-South
state: Florida
city: Indianapolis
country: United States
facility: Franciscan Physician Network Oncology & Hematology
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Morristown
country: United States
facility: Hematology /Oncology Associates of Northern New Jersey
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cincinnati
country: United States
facility: Sarah Cannon Research Institute
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Greenville
country: United States
facility: Saint Francis Hospital
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Midtown
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital, Sydney
state: New South Wales
city: North Gosford
country: Australia
facility: Jarrett Street Specialist Centre
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Adelaide
country: Australia
facility: Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre, Department of Haematology, Level 6
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health, University Hospital Geelong
state: Victoria
city: Antwerpen
country: Belgium
facility: Z N A Stuivenberg
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV Brugge-Oostende
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Winnipeg
country: Canada
facility: Cancercare Manitoba - Maccharles Unit
state: Manitoba
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec - Hôpital de l'Enfant-Jésus
state: Quebec
city: Zagreb
country: Croatia
facility: Klinicka bolnica Dubrava
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur
city: Zagreb
country: Croatia
facility: UHC Zagreb
city: Ostrava-Poruba
country: Czechia
facility: Faculty hospital Ostrava
state: Moravian-Silesian
city: Brno
country: Czechia
facility: University Hospital
city: Hradec Kralove
country: Czechia
facility: Faculty Hospital Hradec Kralove
city: Plzen
country: Czechia
facility: Faculty Hospital Plzen
city: Prague 10
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
city: Lille
country: France
facility: CHRU de Lille, Hopital Claude Huriez
city: Paris
country: France
facility: Hospital Saint-Louis
city: Tours
country: France
facility: CHU Bretonneau
city: Tatabánya
country: Hungary
facility: Szent Borbála Hospital
state: Komárom - Esztergom
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,
state: Somogy
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Debrecen
country: Hungary
facility: University of Debrecen HSC Institute of internal Medicine, Department of Hematology
city: Gyula
country: Hungary
facility: Pandy Kalman Hospital
city: Pecs
country: Hungary
facility: University Of Pecs, Medical School
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika
city: Bari
country: Italy
facility: IRCCS Istituto Tumori
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico Armando Businco
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico di Modena
city: Novara
country: Italy
facility: AOU Maggiore della Carità
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne s.c.
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku
city: Wroclaw
country: Poland
facility: Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
city: Brasov
country: Romania
facility: Emergency County Clinical Hospital Brasov
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Barcelona
country: Spain
facility: Hospital Vall de Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: ICO, Hospitalet de Llobregat
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta De Hierro
city: London
country: United Kingdom
facility: University College London
state: England
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
state: Kent
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Trust
state: Surrey
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust
city: London
country: United Kingdom
facility: Hammersmith Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Trust
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospital NHS Trust, New Cross Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: