Clinical trial NCT01732913: Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 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
Small lymphocytic lymphoma
lymphoplasmacytoid lymphoma
Waldenstrom macroglobulinemia
LPL
WM
Marginal zone lymphoma
MZL
SLL
FL
GS-1101
idelalisib
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 295
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 to 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) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis
  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.
* Received previous treatment with rituximab that was not effective.

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

Primary outcomes:
measure: Progression Free Survival
Secondary outcomes:
measure: Overall Response Rate
measure: Lymph Node Response Rate
measure: Complete Response Rate
measure: Overall Survival
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: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: Fullerton
country: United States
facility: Saint Jude Heritage Healthcare
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates
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: Middletown
country: United States
facility: Middlesex Hospital Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists and Research Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
city: Watertown
country: United States
facility: Prairie Lakes Healthcare System
state: South Dakota
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Bedford
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: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders, PC
state: Texas
city: Winchester
country: United States
facility: Shenandoah Oncology Associates, PC
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital and Medical College of Wisconsin
state: Wisconsin
city: Milton
country: Australia
facility: Haematology and Oncology Clinics of Australia at Chermside
state: Queensland
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: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Pessac
country: France
facility: University Hospital of Bordeaux
state: Aquitaine
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
state: Ile-de-france
city: Lille cedex
country: France
facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
state: NORD Pas-de-calais
city: Brest
country: France
facility: Centre Hospitalier Universitaire Brest
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Lyon Cedex 08
country: France
facility: Centre Léon Bérard
city: Nantes cedex 1
country: France
facility: Hôpital Hôtel-Dieu
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
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: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum
state: Hajdu-bihar
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
state: VAS
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Ein Kerem
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
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: Pordenone
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Nagoya City
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Minami Ku
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Kobe-city
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Chuo-ku
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
state: Kumamoto
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Okayama-city
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
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: Kraków
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
city: Warszawa
country: Poland
facility: Centrum Onkologii i Hipertermii
city: Porto
country: Portugal
facility: Hospital Geral de Santo António do Centro Hospitalar do Porto
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
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: 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: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Gleneagles Medical Centre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus, Malmö
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital (CGMH)
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
state: England
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Infirmary
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: