Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

February 24, 2026 updated by: Pharmacyclics LLC.

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)

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • The Canberra Hospital
    • Queensland
      • South Brisbane, Queensland, Australia
        • Mater Misericordiae Health Services
    • Tasmania
      • Hobart, Tasmania, Australia
        • Royal Hobart Hospital
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Medical Centre Clayton Campus
      • Geelong, Victoria, Australia
        • Andrew Love Cancer Center
  • Austria
      • Salzburg, Austria
        • Uniklinikum Salzburg
    • Tyrol
      • Innsbruck, Tyrol, Austria
        • Universitätsklinikum Innsbruck
  • Belgium
      • Antwerp, Belgium
        • ZNA Stuivenberg
      • Bruges, Belgium
        • AZ Sint-Jan Brugge Oostende AV
      • Ghent, Belgium
        • UZ Gent
      • Liège, Belgium
        • CHU de Liege
      • Sint-Niklaas, Belgium
        • AZ Nikolaas
      • Wilrijk, Belgium
        • Gasthuis Zusters Antwerpen
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium
        • Cliniques Universitaires Saint-luc
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Moncton Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • CIUSSS-de-l'Est-de-l'Ile-de-Montréal
      • Montreal, Quebec, Canada
        • CHUM Notre Dame Hospital
  • Czechia
      • Hradec Králové, Czechia
        • Fakultni nemocnice Hradec Kralove
      • Ostrava, Czechia
        • Fakultni Nemocnice Ostrava
      • Prague, Czechia
        • Fakultni nemocnice v Motole
      • Prague, Czechia
        • Fakultni nemocnice Kralovske Vinohrady
  • France
      • Limoges, France
        • CHU de Limoges Hopital Dupuytren
      • Pessac, France
        • CHU Bordeaux
      • Périgueux, France, 24019
        • Centre Hospitalier de Perigueux
      • Strasbourg, France
        • Hôpital Civil
    • Drôme
      • Valence, Drôme, France
        • Centre Hospitalier de Valence
    • Vienne
      • Poitiers, Vienne, France
        • CHRU de Poitiers La Miletrie
  • Greece
      • Larissa, Greece
        • University General Hospital of Larissa
    • Achaïa
      • Pátrai, Achaïa, Greece
        • University General Hospital of Patras
    • Attica
      • Athens, Attica, Greece
        • Laiko General Hospital of Athens
  • Hungary
      • Budapest, Hungary
        • Orszagos Onkologiai Intezet
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont
      • Győr, Hungary
        • Petz Aladar Megyei Oktato Korhaz
      • Pécs, Hungary
        • Pecsi Tudomanyegyetem
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Haifa, Israel
        • Lady Davis Carmel Medical Center
      • Haifa, Israel
        • Bnei Zion Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center Beilinson Campus
      • Tel Aviv, Israel
        • Assuta Medical Center
      • Ẕerifin, Israel
        • Assaf Harofe Medical Center
  • Italy
      • Aviano, Italy
        • Centro Di Riferimento Oncologico
      • Cuneo, Italy, 12100
        • Azienda Sanitaria Ospedaliera S. Croce e Carle
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
      • Milan, Italy
        • San Raffaele Scientific Institute
      • Milan, Italy
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
      • Parma, Italy
        • Azienda Ospedaliero Universitaria di Parma
      • Roma, Italy
        • Policlinico Universitario Campus Biomedico Di Roma
      • Roma, Italy
        • Farmacia Polo Ematologico Policlinico Umberto I
      • Torino, Italy
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Emilia-Romagna
      • Rimini, Emilia-Romagna, Italy
        • Ospedale Infermi di Rimini
    • Liguria
      • Genoa, Liguria, Italy
        • Ospedale Policlinico San Martino
    • Lombardy
      • Milan, Lombardy, Italy
        • Istituto Europeo di Oncologia
    • Piedmont
      • Turin, Piedmont, Italy
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Tuscany
      • Siena, Tuscany, Italy
        • Azienda ospedaliera Universiataria Senese
  • Netherlands
      • Leiden, Netherlands
        • Leids Universitair Medisch Centrum
      • Tilburg, Netherlands
        • ETZ-Elisabeth
    • Gelderland
      • Apeldoorn, Gelderland, Netherlands
        • Gelre Ziekenhuizen
    • South Holland
      • Rotterdam, South Holland, Netherlands
        • Maasstad Ziekenhuis
  • Poland
      • Krakow, Poland
        • Malopolskie Centrum Medyczne
      • Wroclaw, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland
        • Centrum Onkologii Ziemi Lubelskiej
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland
        • Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
      • Gdynia, Pomeranian Voivodeship, Poland
        • Szpitale Pomorskie Sp. z o. o.
  • Portugal
      • Matosinhos Municipality, Portugal
        • Unidade Local de Saúde de Matosinhos SA
      • Porto, Portugal
        • Centro Hospitalar do Porto - Hospital de Santo António
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de São João, E.P.E.
      • Porto, Portugal
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Russia
      • Krasnoyarsk, Russia
        • Regional Clinical Hospital
      • Moscow, Russia
        • Russian Oncology Research Center n a N N Blokhin
      • Nizhny Novgorod, Russia
        • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
      • Saint Petersburg, Russia
        • City Hospital #31
      • Saint Petersburg, Russia
        • North-West Federal Medical Research Center n.a. V.A. Almazov
  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Spain
        • ICO L'Hospitalet
      • Barcelona, Spain
        • Hospital Vall dHebron
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain
        • Hospital Universitario HM Sanchinarro - CIOCC
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
    • Principality of Asturias
      • Gijón, Principality of Asturias, Spain
        • Hospital de Cabuenes
    • Sevilla
      • Seville, Sevilla, Spain
        • Hospital Universitario Virgen de Valme
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Hospital
      • Kaohsiung City, Taiwan
        • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
      • Liuying, Taiwan
        • Chi Mei Medical Center, Liouying
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Gazi Universitesi Tip Fakultesi Hastanesi
      • Bornova, Turkey (Türkiye)
        • Ege Universitesi Tip Fakultesi Hastanesi
      • Gaziantep, Turkey (Türkiye)
        • Mersin Universitesi Tip Fakultesi Hastanesi
      • Kayseri, Turkey (Türkiye)
        • Erciyes Universitesi Tip Fakultesi Hastanesi
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
      • Samsun, Turkey (Türkiye)
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
      • Tekirdağ, Turkey (Türkiye)
        • Namik Kemal Universitesi Tip Fakultesi Hastanesi
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom
        • Barts and The London NHS Trust
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Reading, United Kingdom
        • Royal Berkshire Hospital NHS Foundation Trust
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital - Hospital Treliske
    • Norfolk
      • Norwich, Norfolk, United Kingdom
        • Norfolk and Norwich University Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36526
        • Southern Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Santa Monica, California, United States, 90095
        • UCLA Hematology/Oncology
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center and Research Institute
    • Florida
      • Fort Myers, Florida, United States, 33916
        • SCRI Florida Cancer Specialists South
      • Ocala, Florida, United States, 34471
        • Florida Cancer Affiliates
      • St. Petersburg, Florida, United States, 33709
        • SCRI Florida Cancer Specialists North
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Goldschmidt Cancer Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
    • Oregon
      • Beaverton, Oregon, United States, 97006
        • OHSU Knight Cancer Institute Beaverton Clinic
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-1108
        • Scri Tennessee Oncology Chattanooga
      • Nashville, Tennessee, United States, 37203
        • SCRI Tennessee Oncology Nashville
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Oncology-Dallas Presbyterian Hospital
      • Dallas, Texas, United States, 75230
        • Texas Oncology (Medical City)
      • Fort Worth, Texas, United States, 76104
        • SCRI The Center For Cancer and Blood Disorders
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Tyler, Texas, United States, 75702
        • Texas Oncology (Tyler)
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Oncology and Hematology Associates of Southwest Virginia (Blacksburg)
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • W VA University Mary Babb Randolph Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Arm A) ibrutinib + rituximab
Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
Drug: Ibrutinib Oral Capsule
Ibrutinib 560mg administered orally daily
Other Names:
  • Imbruvica
Drug: Rituximab
Rituximab 375mg/m^2 intravenously (IV) weekly
Placebo Comparator: (Arm B) placebo + rituximab
Participants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
Drug: Rituximab
Rituximab 375mg/m^2 intravenously (IV) weekly
Drug: Placebo
Placebo capsules to match ibrutinib administered orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator
Time Frame: Primary Analysis cut-off; median overall follow-up of 53.75 months
PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma [Cheson 2014, Lugano Classification]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.
Primary Analysis cut-off; median overall follow-up of 53.75 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) as Assessed by Investigator
Time Frame: Primary Analysis; median overall follow-up of 53.75 months
ORR is the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) as determined by the investigator according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014, Lugano Classification). ORR was assessed from the date of randomization through the date of first documented disease progression or initiation of subsequent anti-cancer therapy, whichever occurred first. Participants who did not have any post-baseline disease assessments or who initiated subsequent anti-cancer therapy prior to a documented response are considered non-responders.
Primary Analysis; median overall follow-up of 53.75 months
Overall Survival (OS)
Time Frame: Final Analysis; median overall follow-up of 58.97 months
Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause. If a participant is not known to have died (this includes participants with unknown death date), OS will be censored at the date the participant was last known to have been alive. Estimated by Kaplan-Meier method.
Final Analysis; median overall follow-up of 58.97 months
Infusion-related Reaction Rate Assessed by Investigator
Time Frame: Primary Analysis; median overall follow-up of 53.75 months
The infusion-related reactions (IRR) rate is the proportion of subjects experiencing infusion related reactions that start on the day of a rituximab infusion and are assessed as related or possibly related to rituximab.
Primary Analysis; median overall follow-up of 53.75 months
Duration of Response (DOR) as Assessed by Investigator
Time Frame: Primary Analysis; median overall follow-up of 53.75 months
DOR is defined as the time from initial complete response (CR) or partial response (PR) to progressive disease (PD) or death due to any cause, whichever is first reported, regardless of discontinuation of study treatment. If such event did not occur, then participants were to be censored at the last adequate disease assessment as required for PFS censoring. Estimated by Kaplan-Meier method.
Primary Analysis; median overall follow-up of 53.75 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Overall median treatment duration of 22.11 months
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. The treatment-emergent period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent anti-cancer therapy, whichever comes first. The treatment-emergent adverse events (TEAEs) are those events that occur or worsen during the treatment-emergent period or that are related to the study treatment.
Overall median treatment duration of 22.11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Collaborators

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

February 21, 2024

Study Completion (Actual)

June 9, 2025

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimated)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-1141-CA
  • 2016-003202-14 (EudraCT Number)
  • 2023-507271-21-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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