Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
NCT ID: NCT02947347
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
445 participants
INTERVENTIONAL
2017-01-31
2025-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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(Arm A) ibrutinib + rituximab
Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance.
ibrutinib
ibrutinib 560mg administered orally
rituximab
rituximab 375mg/m\^2 IV
(Arm B) placebo + rituximab
Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance.
placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally
rituximab
rituximab 375mg/m\^2 IV
Interventions
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ibrutinib
ibrutinib 560mg administered orally
placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally
rituximab
rituximab 375mg/m\^2 IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
* Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Adequate hematologic function within protocol-defined parameters.
* Adequate hepatic and renal function within protocol-defined parameters.
* ECOG performance status score of 0-2.
Exclusion Criteria
* Prior treatment for follicular lymphoma.
* Central nervous system lymphoma or leptomeningeal disease.
* Currently active, clinically significant cardiovascular disease.
60 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Locations
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Southern Cancer Center
Mobile, Alabama, United States
City of Hope
Duarte, California, United States
Sansum Clinic
Santa Barbara, California, United States
UCLA Hematology/Oncology
Santa Monica, California, United States
Helen F. Graham Cancer Center and Research Institute
Newark, Delaware, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Florida Cancer Affiliates
Ocala, Florida, United States
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
OHSU Knight Cancer Institute Beaverton Clinic
Beaverton, Oregon, United States
Greenville Health System
Greenville, South Carolina, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, United States
Texas Oncology (Medical City)
Dallas, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States
SCRI The Center For Cancer and Blood Disorders
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology (Tyler)
Tyler, Texas, United States
Oncology and Hematology Associates of Southwest Virginia (Blacksburg)
Blacksburg, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Medical Oncology Associates
Spokane, Washington, United States
W VA University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Mater Misericordiae Health Services
South Brisbane, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Monash Medical Centre Clayton Campus
Clayton, Victoria, Australia
Andrew Love Cancer Center
Geelong, Victoria, Australia
Universitätsklinikum Innsbruck
Innsbruck, Tyrol, Austria
Uniklinikum Salzburg
Salzburg, , Austria
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
ZNA Stuivenberg
Antwerp, , Belgium
AZ Sint-Jan Brugge Oostende AV
Bruges, , Belgium
UZ Gent
Ghent, , Belgium
CHU de Liège
Liège, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
Gasthuis Zusters Antwerpen
Wilrijk, , Belgium
Moncton Hospital
Moncton, New Brunswick, Canada
CHUM Notre Dame Hospital
Montreal, Quebec, Canada
CIUSSS-de-l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Centre Hospitalier de Valence
Valence, Drôme, France
CHRU de Poitiers La Miletrie
Poitiers, Vienne, France
CHU de Limoges Hôpital Dupuytren
Limoges, , France
CHU Bordeaux
Pessac, , France
Centre Hospitalier de Perigueux
Périgueux, , France
Hôpital Civil
Strasbourg, , France
University General Hospital of Patras
Pátrai, Achaïa, Greece
Laiko General Hospital of Athens
Athens, Attica, Greece
University General Hospital of Larissa
Larissa, , Greece
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Petz Aladár Megyei Oktató Kórház
Győr, , Hungary
Pécsi Tudományegyetem
Pécs, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Bnei Zion Medical Center
Haifa, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, , Israel
Assuta Medical Center
Tel Aviv, , Israel
Assaf Harofe Medical Center
Ẕerifin, , Israel
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, Italy
Ospedale Policlinico San Martino
Genoa, Liguria, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Azienda ospedaliera Universiataria Senese
Siena, Tuscany, Italy
Centro Di Riferimento Oncologico
Aviano, , Italy
Azienda Sanitaria Ospedaliera S. Croce e Carle
Cuneo, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
Meldola, , Italy
San Raffaele Scientific Institute
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Farmacia Polo Ematologico Policlinico Umberto I
Roma, , Italy
Policlinico Universitario Campus Biomedico di Roma
Roma, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
ETZ-Elisabeth
Tilburg, , Netherlands
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lublin Voivodeship, Poland
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia, Pomeranian Voivodeship, Poland
Malopolskie Centrum Medyczne
Krakow, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, , Poland
Unidade Local de Saúde de Matosinhos SA
Matosinhos Municipality, , Portugal
Centro Hospitalar de São João, E.P.E.
Porto, , Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto, , Portugal
Regional Clinical Hospital
Krasnoyarsk, , Russia
Russian Oncology Research Center n a N N Blokhin
Moscow, , Russia
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, , Russia
City Hospital #31
Saint Petersburg, , Russia
North-West Federal Medical Research Center n.a. V.A. Almazov
Saint Petersburg, , Russia
Hospital de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Virgen de Valme
Seville, Sevilla, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, , Spain
Hospital Vall dHebron
Barcelona, , Spain
ICO L'Hospitalet
Barcelona, , Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Chi Mei Medical Center, Liouying
Liuying, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Gazi Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Gaziantep, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
Kocaeli, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , Turkey (Türkiye)
Namik Kemal Universitesi Tip Fakultesi Hastanesi
Tekirdağ, , Turkey (Türkiye)
Royal Cornwall Hospital - Hospital Treliske
Tururo, Cornwall, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Barts and The London NHS Trust
London, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Royal Berkshire Hospital NHS Foundation Trust
Reading, , United Kingdom
Countries
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Other Identifiers
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2016-003202-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCYC-1141-CA
Identifier Type: -
Identifier Source: org_study_id
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