Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
- Conditions
- Follicular Lymphoma
- Interventions
- Registration Number
- NCT02947347
- Lead Sponsor
- Pharmacyclics LLC.
- Brief Summary
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 445
- Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
- 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.
- Transformed lymphoma
- Prior treatment for follicular lymphoma.
- Central nervous system lymphoma or leptomeningeal disease.
- Currently active, clinically significant cardiovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (Arm A) ibrutinib + rituximab ibrutinib Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance. (Arm A) ibrutinib + rituximab rituximab Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance. (Arm B) placebo + rituximab rituximab Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance. (Arm B) placebo + rituximab placebo to match ibrutinib Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance.
- Primary Outcome Measures
Name Time Method Number of Participants with Progression-Free Survival (PFS) 2-5 years PFS, is assessed by the investigator, will be analyzed in the intent to treat (ITT) population, comparing the 2 treatment arms (Arm A and Arm B).
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) 2-5 years ORR of the two treatment arms will be compared using the Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by the randomization stratification factors, under the hierarchical procedure.
Overall Survival 2-5 years Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause.
Infusion-Related Reaction Rate 2-5 years Infusion-related reaction rate Arm A vs. Arm B.
Duration of Response (DOR) as Assessed by Investigator 2-5 years DOR is defined as the time from the date of the participant's documented disease progression or death due to the disease, whichever occurs first.
Number of Participants with Adverse Events (AE) 2-5 years An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Trial Locations
- Locations (127)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Centro Hospitalar do Porto - Hospital de Santo António
🇵🇹Porto, Portugal
Ospedale Policlinico San Martino
🇮🇹Genova, Liguria, Italy
University General Hospital of Patras
🇬🇷Patras, Achaïa, Greece
University General Hospital of Larissa
🇬🇷Larissa, Greece
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
🇵🇱Wroclaw, Poland
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Unidade Local de Saúde de Matosinhos SA
🇵🇹Matosinhos, Portugal
SCRI Tennessee Oncology Nashville
🇺🇸Nashville, Tennessee, United States
SCRI Florida Cancer Specialists South
🇺🇸Fort Myers, Florida, United States
Helen F. Graham Cancer Center and Research Institute
🇺🇸Newark, Delaware, United States
City of Hope
🇺🇸Duarte, California, United States
Texas Oncology-Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
UCLA Hematology/Oncology
🇺🇸Santa Monica, California, United States
Goldschmidt Cancer Center
🇺🇸Jefferson City, Missouri, United States
AZ Sint-Jan Brugge Oostende AV
🇧🇪Bruges, Belgium
Monash Medical Centre Clayton Campus
🇦🇺Clayton, Victoria, Australia
Southern Cancer Center
🇺🇸Mobile, Alabama, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
SCRI Florida Cancer Specialists North
🇺🇸Saint Petersburg, Florida, United States
Texas Oncology (Medical City)
🇺🇸Dallas, Texas, United States
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
SCRI Tennessee Oncology Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Oncology and Hematology Associates of Southwest Virginia (Blacksburg)
🇺🇸Blacksburg, Virginia, United States
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Brussels, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
CHUM Notre Dame Hospital
🇨🇦Montréal, Quebec, Canada
W VA University Mary Babb Randolph Cancer Center
🇺🇸Morgantown, West Virginia, United States
SCRI The Center For Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
OHSU Knight Cancer Institute Beaverton Clinic
🇺🇸Beaverton, Oregon, United States
Medical Oncology Associates
🇺🇸Spokane, Washington, United States
Ospedale Infermi di Rimini
🇮🇹Rimini, Emilia-Romagna, Italy
Országos Onkológiai Intézet
🇭🇺Budapest, Hungary
Universitätsklinikum Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Somogy Megyei Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Somogy, Hungary
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
CIUSSS-de-l'Est-de-l'Île-de-Montréal
🇨🇦Montreal, Quebec, Canada
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
🇮🇹Meldola, Italy
Laiko General Hospital of Athens
🇬🇷Athens, Attiki, Greece
Pécsi Tudományegyetem
🇭🇺Pecs, Hungary
UZ Gent
🇧🇪Gent, Belgium
Gasthuis Zusters Antwerpen
🇧🇪Wilrijk, Belgium
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
CHRU de Poitiers La Miletrie
🇫🇷Poitiers, Vienne, France
CHU de Liège
🇧🇪Liège, Belgium
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Centre Hospitalier de Valence
🇫🇷Valence, Drôme, France
Petz Aladár Megyei Oktató Kórház
🇭🇺Gyor, Hungary
Bnei Zion Medical Center
🇮🇱Haifa, Israel
Assuta Medical Center
🇮🇱Tel Aviv, Israel
CHU Bordeaux
🇫🇷Pessac, France
ETZ-Elisabeth
🇳🇱Tilburg, Netherlands
San Raffaele Scientific Institute
🇮🇹Milan, Italy
Hospital Universitario Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Russian Oncology Research Center n a N N Blokhin
🇷🇺Moscow, Russian Federation
Hospital Universitario Virgen de Valme
🇪🇸Seville, Sevilla, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Centrum Onkologii Ziemi Lubelskiej
🇵🇱Lublin, Lubelskie, Poland
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
🇵🇱Gdansk, Pomorskie, Poland
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
🇵🇹Porto, Portugal
North-West Federal Medical Research Center n.a. V.A. Almazov
🇷🇺Saint Petersburg, Russian Federation
Hospital Vall dHebron
🇪🇸Barcelona, Spain
Maasstad Ziekenhuis
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Szpitale Pomorskie Sp. z o. o.
🇵🇱Gdynia, Pomorskie, Poland
Gelre Ziekenhuizen
🇳🇱Apeldoorn, Gelderland, Netherlands
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
City Hospital #31
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario HM Sanchinarro - CIOCC
🇪🇸Madrid, Spain
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Royal Cornwall Hospital - Hospital Treliske
🇬🇧Tururo, Cornwall, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, Norfolk, United Kingdom
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Chi Mei Medical Center, Liouying
🇨🇳Liuying, Taiwan
Mersin Universitesi Tip Fakultesi Hastanesi
🇹🇷Gaziantep, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
🇹🇷Samsun, Turkey
Royal Berkshire Hospital NHS Foundation Trust
🇬🇧Reading, United Kingdom
Barts and The London NHS Trust
🇬🇧London, United Kingdom
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Erciyes Universitesi Tip Fakultesi Hastanesi
🇹🇷Kayseri, Turkey
Farmacia Polo Ematologico Policlinico Umberto I
🇮🇹Roma, Italy
Policlinico Universitario Campus Biomedico di Roma
🇮🇹Roma, Italy
Gazi Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
🇹🇷Kocaeli, Turkey
Centre Hospitalier de Perigueux
🇫🇷Perigueux, France
ICO L'Hospitalet
🇪🇸Barcelona, Spain
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Florida Cancer Affiliates
🇺🇸Ocala, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Texas Oncology (Tyler)
🇺🇸Tyler, Texas, United States
Mater Misericordiae Health Services
🇦🇺South Brisbane, Queensland, Australia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha, Czechia
CHU de Limoges Hôpital Dupuytren
🇫🇷Limoges, France
Hôpital Civil
🇫🇷Strasbourg, France
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Rabin Medical Center Beilinson Campus
🇮🇱Petah Tikva, Israel
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Assaf Harofe Medical Center
🇮🇱Zerifin, Israel
Istituto Europeo Di Oncologia
🇮🇹Milan, Lombardia, Italy
Azienda ospedaliera Universiataria Senese
🇮🇹Siena, Toscana, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Centro Di Riferimento Oncologico
🇮🇹Aviano, Italy
Azienda Sanitaria Ospedaliera S. Croce e Carle
🇮🇹Cuneo, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Centro Hospitalar de São João, E.P.E.
🇵🇹Porto, Portugal
Regional Clinical Hospital
🇷🇺Krasnoyarsk, Russian Federation
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Ege Universitesi Tip Fakultesi Hastanesi
🇹🇷Bornova, Turkey
Namik Kemal Universitesi Tip Fakultesi Hastanesi
🇹🇷Tekirdağ, Turkey
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Andrew Love Cancer Center
🇦🇺Geelong, Victoria, Australia