Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Follicular Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02947347
• Other study ID #: PCYC-1141-CA
• Secondary ID: 2016-003202-14
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: June 25, 2026

Study information

• Verified date: June 2024
• Source: Pharmacyclics LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 445
• Est. completion date: June 25, 2026
• Est. primary completion date: June 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• ibrutinib
ibrutinib 560mg administered orally
• placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally
• rituximab
rituximab 375mg/m^2 IV

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics LLC.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Greece,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Progression-Free Survival (PFS)	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).	2-5 years
Secondary	Overall Response Rate (ORR)	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.	2-5 years
Secondary	Overall Survival	Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause.	2-5 years
Secondary	Infusion-Related Reaction Rate	Infusion-related reaction rate Arm A vs. Arm B.	2-5 years
Secondary	Duration of Response (DOR) as Assessed by Investigator	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.	2-5 years
Secondary	Number of Participants with Adverse Events (AE)	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.	2-5 years