Clinical trial NCT02947347: Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 445
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Transformed lymphoma
* Prior treatment for follicular lymphoma.
* Central nervous system lymphoma or leptomeningeal disease.
* Currently active, clinically significant cardiovascular disease.

Primary outcomes:
measure: Number of Participants with Progression-Free Survival (PFS)
timeFrame: 2-5 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 2-5 years
measure: Overall Survival
timeFrame: 2-5 years
measure: Infusion-Related Reaction Rate
timeFrame: 2-5 years
measure: Duration of Response (DOR) as Assessed by Investigator
timeFrame: 2-5 years
measure: Number of Participants with Adverse Events (AE)
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Newark
country: United States
facility: Helen F. Graham Cancer Center and Research Institute
state: Delaware
city: Fort Myers
country: United States
facility: SCRI Florida Cancer Specialists South
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates
state: Florida
city: Saint Petersburg
country: United States
facility: SCRI Florida Cancer Specialists North
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Jefferson City
country: United States
facility: Goldschmidt Cancer Center
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Beaverton
country: United States
facility: OHSU Knight Cancer Institute Beaverton Clinic
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: SCRI Tennessee Oncology Nashville
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology (Medical City)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital
state: Texas
city: Fort Worth
country: United States
facility: SCRI The Center For Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology (Tyler)
state: Texas
city: Blacksburg
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia (Blacksburg)
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Morgantown
country: United States
facility: W VA University Mary Babb Randolph Cancer Center
state: West Virginia
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: South Brisbane
country: Australia
facility: Mater Misericordiae Health Services
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton Campus
state: Victoria
city: Geelong
country: Australia
facility: Andrew Love Cancer Center
state: Victoria
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck
state: Tirol
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Bruges
country: Belgium
facility: AZ Sint-Jan Brugge Oostende AV
city: Gent
country: Belgium
facility: UZ Gent
city: Liège
country: Belgium
facility: CHU de Liège
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Wilrijk
country: Belgium
facility: Gasthuis Zusters Antwerpen
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: Montreal
country: Canada
facility: CIUSSS-de-l'Est-de-l'Île-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: CHUM Notre Dame Hospital
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Valence
country: France
facility: Centre Hospitalier de Valence
state: Drôme
city: Poitiers
country: France
facility: CHRU de Poitiers La Miletrie
state: Vienne
city: Limoges
country: France
facility: CHU de Limoges Hôpital Dupuytren
city: Perigueux
country: France
facility: Centre Hospitalier de Perigueux
city: Pessac
country: France
facility: CHU Bordeaux
city: Strasbourg
country: France
facility: Hôpital Civil
city: Patras
country: Greece
facility: University General Hospital of Patras
state: Achaïa
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Bnei Zion Medical Center
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
state: Emilia-Romagna
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: Liguria
city: Milan
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
state: Piemonte
city: Siena
country: Italy
facility: Azienda ospedaliera Universiataria Senese
state: Toscana
city: Aviano
country: Italy
facility: Centro Di Riferimento Oncologico
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera S. Croce e Carle
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
city: Milan
country: Italy
facility: San Raffaele Scientific Institute
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Roma
country: Italy
facility: Farmacia Polo Ematologico Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico di Roma
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
state: Gelderland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Tilburg
country: Netherlands
facility: ETZ-Elisabeth
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
state: Lubelskie
city: Gdansk
country: Poland
facility: Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
state: Pomorskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.
state: Pomorskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos SA
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo António
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
city: Krasnoyarsk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n a N N Blokhin
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #31
city: Saint Petersburg
country: Russian Federation
facility: North-West Federal Medical Research Center n.a. V.A. Almazov
city: Gijón
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Seville
country: Spain
facility: Hospital Universitario Virgen de Valme
state: Sevilla
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Vall dHebron
city: Barcelona
country: Spain
facility: ICO L'Hospitalet
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro - CIOCC
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Liuying
country: Taiwan
facility: Chi Mei Medical Center, Liouying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi Hastanesi
city: Bornova
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Gaziantep
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Tekirdağ
country: Turkey
facility: Namik Kemal Universitesi Tip Fakultesi Hastanesi
city: Tururo
country: United Kingdom
facility: Royal Cornwall Hospital - Hospital Treliske
state: Cornwall
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital NHS Foundation Trust
Study officials:
References: