Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

445

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

February 21, 2024

Study Completion Date

June 9, 2025

Conditions
Follicular Lymphoma
Interventions
DRUG

ibrutinib

ibrutinib 560mg administered orally

DRUG

placebo to match ibrutinib

placebo capsules to match ibrutinib administered orally

DRUG

rituximab

rituximab 375mg/m\^2 IV

Trial Locations (128)

7400

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

12100

Azienda Sanitaria Ospedaliera S. Croce e Carle, Cuneo

24019

Centre Hospitalier de Perigueux, Périgueux

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST, Meldola

Unknown

Southern Cancer Center, Mobile

City of Hope, Duarte

Sansum Clinic, Santa Barbara

UCLA Hematology/Oncology, Santa Monica

Helen F. Graham Cancer Center and Research Institute, Newark

SCRI Florida Cancer Specialists South, Fort Myers

Florida Cancer Affiliates, Ocala

SCRI Florida Cancer Specialists North, St. Petersburg

Rush University Medical Center, Chicago

Norton Cancer Institute, Louisville

Goldschmidt Cancer Center, Jefferson City

Southeast Nebraska Cancer Center, Lincoln

OHSU Knight Cancer Institute Beaverton Clinic, Beaverton

Greenville Health System, Greenville

SCRI Tennessee Oncology Chattanooga, Chattanooga

SCRI Tennessee Oncology Nashville, Nashville

Texas Oncology (Medical City), Dallas

Texas Oncology-Dallas Presbyterian Hospital, Dallas

SCRI The Center For Cancer and Blood Disorders, Fort Worth

MD Anderson Cancer Center, Houston

Texas Oncology (Tyler), Tyler

Oncology and Hematology Associates of Southwest Virginia (Blacksburg), Blacksburg

Swedish Cancer Institute, Seattle

Medical Oncology Associates, Spokane

W VA University Mary Babb Randolph Cancer Center, Morgantown

The Canberra Hospital, Garran

Mater Misericordiae Health Services, South Brisbane

Royal Hobart Hospital, Hobart

Monash Medical Centre Clayton Campus, Clayton

Andrew Love Cancer Center, Geelong

Universitätsklinikum Innsbruck, Innsbruck

Uniklinikum Salzburg, Salzburg

Cliniques Universitaires Saint-Luc, Brussels

ZNA Stuivenberg, Antwerp

AZ Sint-Jan Brugge Oostende AV, Bruges

UZ Gent, Ghent

CHU de Liège, Liège

AZ Nikolaas, Sint-Niklaas

Gasthuis Zusters Antwerpen, Wilrijk

Moncton Hospital, Moncton

CHUM Notre Dame Hospital, Montreal

CIUSSS-de-l'Est-de-l'Île-de-Montréal, Montreal

Fakultni nemocnice Hradec Kralove, Hradec Králové

Fakultni nemocnice Ostrava, Ostrava

Fakultni nemocnice Kralovske Vinohrady, Prague

Fakultni nemocnice v Motole, Prague

Centre Hospitalier de Valence, Valence

CHRU de Poitiers La Miletrie, Poitiers

CHU de Limoges Hôpital Dupuytren, Limoges

CHU Bordeaux, Pessac

Hôpital Civil, Strasbourg

University General Hospital of Patras, Pátrai

Laiko General Hospital of Athens, Athens

University General Hospital of Larissa, Larissa

Országos Onkológiai Intézet, Budapest

Debreceni Egyetem Klinikai Kozpont, Debrecen

Petz Aladár Megyei Oktató Kórház, Győr

Pécsi Tudományegyetem, Pécs

Barzilai Medical Center, Ashkelon

Bnei Zion Medical Center, Haifa

Lady Davis Carmel Medical Center, Haifa

Rabin Medical Center Beilinson Campus, Petah Tikva

Assuta Medical Center, Tel Aviv

Assaf Harofe Medical Center, Ẕerifin

Ospedale Infermi di Rimini, Rimini

Ospedale Policlinico San Martino, Genoa

Istituto Europeo Di Oncologia, Milan

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin

Azienda ospedaliera Universiataria Senese, Siena

Centro Di Riferimento Oncologico, Aviano

San Raffaele Scientific Institute, Milan

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milan

Azienda Ospedaliero Universitaria di Parma, Parma

Farmacia Polo Ematologico Policlinico Umberto I, Roma

Policlinico Universitario Campus Biomedico di Roma, Roma

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

Gelre Ziekenhuizen, Apeldoorn

Maasstad Ziekenhuis, Rotterdam

Leids Universitair Medisch Centrum, Leiden

ETZ-Elisabeth, Tilburg

Centrum Onkologii Ziemi Lubelskiej, Lublin

Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk

Szpitale Pomorskie Sp. z o. o., Gdynia

Malopolskie Centrum Medyczne, Krakow

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw

Unidade Local de Saúde de Matosinhos SA, Matosinhos Municipality

Centro Hospitalar do Porto - Hospital de Santo António, Porto

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe, Porto

Regional Clinical Hospital, Krasnoyarsk

Russian Oncology Research Center n a N N Blokhin, Moscow

Nizhegorodskaya Regional Clinical Hospital n.a. Semashko, Nizhny Novgorod

City Hospital #31, Saint Petersburg

North-West Federal Medical Research Center n.a. V.A. Almazov, Saint Petersburg

Hospital de Cabueñes, Gijón

Hospital Universitario Virgen de Valme, Seville

Hospital del Mar, Barcelona

Hospital Universitario Germans Trias i Pujol, Barcelona

Hospital Vall dHebron, Barcelona

ICO L'Hospitalet, Barcelona

Hospital Universitario HM Sanchinarro - CIOCC, Madrid

Hospital Universitario Infanta Leonor, Madrid

Hospital Universitario La Paz, Madrid

Hospital Arnau de Vilanova, Valencia

Hospital Clinico Universitario de Valladolid, Valladolid

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Kaohsiung Medical University Hospital, Kaohsiung City

Chi Mei Medical Center, Liouying, Liuying

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Gazi Universitesi Tip Fakultesi Hastanesi, Ankara

Ege Universitesi Tip Fakultesi Hastanesi, Bornova

Mersin Universitesi Tip Fakultesi Hastanesi, Gaziantep

Erciyes Universitesi Tip Fakultesi Hastanesi, Kayseri

Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi, Kocaeli

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

Namik Kemal Universitesi Tip Fakultesi Hastanesi, Tekirdağ

Norfolk and Norwich University Hospital, Norwich

Addenbrooke's Hospital, Cambridge

Leeds Teaching Hospitals NHS Trust, Leeds

Barts and The London NHS Trust, London

Derriford Hospital, Plymouth

Royal Berkshire Hospital NHS Foundation Trust, Reading

4200-319

Centro Hospitalar de São João, E.P.E., Porto

TR1 3LJ

Royal Cornwall Hospital - Hospital Treliske, Tururo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacyclics LLC.

INDUSTRY

NCT02947347 - Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma | Biotech Hunter | Biotech Hunter