Clinical trial NCT01732926: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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 Indolent Non-Hodgkin Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Indolent Non-Hodgkin's Lymphomas
Keywords: iNHL
indolent NHL
follicular lymphoma
CAL-101
rituximab
bendamustine
small lymphocytic lymphoma
lymphoplasmacytoid lymphoma
Waldenstrom macroglobulinemia
LPL
WM
Marginal zone lymphoma
MZL
SLL
FL
GS-1101
PI3K inhibitor
idelalisib
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 475
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 addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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:

* Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

  1. Follicular lymphoma (FL) Grade 1, 2, or 3a
  2. Small lymphocytic lymphoma (SLL)
  3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
  4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key Exclusion Criteria:

* History of lymphoid malignancy other than those allowed per inclusion criteria.
* Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
* Prior treatment with bendamustine that was not effective.

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

Primary outcomes:
measure: Progression-free Survival (PFS)
Secondary outcomes:
measure: Complete Response Rate (CR)
measure: Overall Response Rate (ORR)
measure: Lymph Node Response Rate
measure: Overall Survival (OS)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center (Bakersfield)
state: California
city: Fullerton
country: United States
facility: Saint Jude Heritage Healthcare (TORI)
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates
state: California
city: San Luis Obispo
country: United States
facility: San Luis Obispo Oncology and Hematology
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Group
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare System
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Vallejo Medical Center
state: California
city: Deerfield Beach
country: United States
facility: Sylvester Comprehensive Cancer Center/UMHC
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates Ltd.
state: Illinois
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: East Setauket
country: United States
facility: North Shore Hematology/Oncology Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Greenville
country: United States
facility: Bon Secours Saint Francis Hospital
state: South Carolina
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Harlingen
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialists
state: Washington
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital and Medical College of Wisconsin
state: Wisconsin
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Haematology and Oncology Clinics of Australia Gold Coast
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: Saint Vincent's Hospital
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials, Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Hôpital Charles Lemoyne
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier Affilie Universitaire de Quebec
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
city: Ostrava - Poruba
country: Czechia
facility: Fakultní Nemocnice Ostrava
state: Severomoravsky KRAJ
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Metz Cedex 03
country: France
facility: CHR Metz
state: Alsace
city: Strasbourg Cedex
country: France
facility: Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
state: Alsace
city: Bordeaux Cedex
country: France
facility: Institut Bergonié
state: Aquitaine
city: Rouen Cedex 1
country: France
facility: Centre Henri-Becquerel
state: Haute-normandie
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
state: Ile-de-france
city: Le Mans
country: France
facility: Centre Jean Bernard
state: PAYS DE LA Loire
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone-alpes
city: Brest Cedex
country: France
facility: Centre Hospitalier Universitaire Brest
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départmental La Roche sur Yon
city: Lyon Cedex 08
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes cedex 1
country: France
facility: Hôpital Hôtel-Dieu
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Tours
country: France
facility: Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
state: Baden-wuerttemberg
city: Kassel
country: Germany
facility: Gemeinschaftspraxis Dres. Söling Und Siehl
state: Hessen
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Charite - Campus Virchow
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Corp.
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Ein Kerem
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: Spedali Civili Di Brescia Azienda Ospedaliera
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Ospedale San Raffaele-IRCCS
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
city: Piacenza
country: Italy
facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Lublin
country: Poland
facility: Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
city: Lódz
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
city: Slupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Warszawa
country: Poland
facility: Centrum Onkologii i Hipertermii
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
city: Ekaterinburg
country: Russian Federation
facility: Central City Hospital # 7
city: Moscow
country: Russian Federation
facility: N. N. Blokhin Russian Cancer Research Center
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology
city: Saint Petersburg
country: Russian Federation
facility: FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg I.P. Pavlov State Medical University
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Volgograd
country: Russian Federation
facility: State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: San Cristobal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fé de Valencia
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset
state: Stockholm
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Changhua city
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: England
city: Dorset
country: United Kingdom
facility: Royal Bournemouth General Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: England
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
state: England
city: London
country: United Kingdom
facility: University College London Hospitals National Health Society Foundation Trust
state: England
city: London
country: United Kingdom
facility: Guys and Saint Thomas NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: England
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
state: England
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: