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Follicular LymphomaPhase 3NCT02947347

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

A Phase 3 study testing Ibrutinib Oral Capsule and Rituximab in people with Follicular Lymphoma, run by Pharmacyclics LLC. at 128 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Ibrutinib Oral Capsule and Rituximab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
445 participants
Where
128 sitesin 19 countries
Study dates
23 Jan 2017to 9 Jun 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

128 sites in 19 countries.

128 sites in 19 countries

United States25 sites

  • OHSU Knight Cancer Institute Beaverton Clinic

    Beaverton, Oregon, 97006

  • Oncology and Hematology Associates of Southwest Virginia (Blacksburg)

    Blacksburg, Virginia, 24060

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404-1108

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Texas Oncology (Medical City)

    Dallas, Texas, 75230

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • City of Hope

    Duarte, California, 91010

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • SCRI The Center For Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Greenville Health System

    Greenville, South Carolina, 29605

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Southern Cancer Center

    Mobile, Alabama, 36526

  • W VA University Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • SCRI Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Helen F. Graham Cancer Center and Research Institute

    Newark, Delaware, 19713

  • Florida Cancer Affiliates

    Ocala, Florida, 34471

  • Sansum Clinic

    Santa Barbara, California, 93105

  • UCLA Hematology/Oncology

    Santa Monica, California, 90095

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • SCRI Florida Cancer Specialists North

    St. Petersburg, Florida, 33709

  • Texas Oncology (Tyler)

    Tyler, Texas, 75702

Other trials in United States

Italy14 sites

  • Centro Di Riferimento Oncologico

    Aviano

  • Azienda Sanitaria Ospedaliera S. Croce e Carle

    Cuneo, 12100

  • Ospedale Policlinico San Martino

    Genoa, Liguria

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

    Meldola, 47014

  • Istituto Europeo Di Oncologia

    Milan, Lombardy

  • San Raffaele Scientific Institute

    Milan

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

    Milan

  • Azienda Ospedaliero Universitaria di Parma

    Parma

  • Ospedale Infermi di Rimini

    Rimini, Emilia-Romagna

  • Farmacia Polo Ematologico Policlinico Umberto I

    Roma

  • Policlinico Universitario Campus Biomedico di Roma

    Roma

  • Azienda ospedaliera Universiataria Senese

    Siena, Tuscany

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont

Other trials in Italy

Spain11 sites

  • Hospital del Mar

    Barcelona

  • Hospital Universitario Germans Trias i Pujol

    Barcelona

  • Hospital Vall dHebron

    Barcelona

  • ICO L'Hospitalet

    Barcelona

  • Hospital de Cabueñes

    Gijón, Principality of Asturias

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid

  • Hospital Universitario Infanta Leonor

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Virgen de Valme

    Seville, Sevilla

  • Hospital Arnau de Vilanova

    Valencia

  • Hospital Clinico Universitario de Valladolid

    Valladolid

Other trials in Spain

Belgium7 sites

  • ZNA Stuivenberg

    Antwerp

  • AZ Sint-Jan Brugge Oostende AV

    Bruges

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital

  • UZ Gent

    Ghent

  • CHU de Liège

    Liège

  • AZ Nikolaas

    Sint-Niklaas

  • Gasthuis Zusters Antwerpen

    Wilrijk

Other trials in Belgium

Turkey (Türkiye)7 sites

  • 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

Other trials in Turkey (Türkiye)

United Kingdom7 sites

  • Addenbrooke's Hospital

    Cambridge

  • Leeds Teaching Hospitals NHS Trust

    Leeds

  • Barts and The London NHS Trust

    London

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk

  • Derriford Hospital

    Plymouth

  • Royal Berkshire Hospital NHS Foundation Trust

    Reading

  • Royal Cornwall Hospital - Hospital Treliske

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

France6 sites

  • CHU de Limoges Hôpital Dupuytren

    Limoges

  • Centre Hospitalier de Perigueux

    Périgueux, 24019

  • CHU Bordeaux

    Pessac

  • CHRU de Poitiers La Miletrie

    Poitiers, Vienne

  • Hôpital Civil

    Strasbourg

  • Centre Hospitalier de Valence

    Valence, Drôme

Other trials in France

Israel6 sites

  • 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

    Tsrifin

Other trials in Israel

Australia5 sites

  • Monash Medical Centre Clayton Campus

    Clayton, Victoria

  • The Canberra Hospital

    Garran, Australian Capital Territory

  • Andrew Love Cancer Center

    Geelong, Victoria

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Mater Misericordiae Health Services

    South Brisbane, Queensland

Other trials in Australia

Hungary5 sites

  • Országos Onkológiai Intézet

    Budapest

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen

  • Petz Aladár Megyei Oktató Kórház

    Győr

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy County, 7400

  • Pécsi Tudományegyetem

    Pécs

Other trials in Hungary

Poland5 sites

  • Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii

    Gdansk, Pomeranian Voivodeship

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, Pomeranian Voivodeship

  • Malopolskie Centrum Medyczne

    Krakow

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, Lublin Voivodeship

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw

Other trials in Poland

Russia5 sites

  • 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

Other trials in Russia

Taiwan5 sites

  • 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

Other trials in Taiwan

Czechia4 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové

  • Fakultni nemocnice Ostrava

    Ostrava

  • Fakultni nemocnice Kralovske Vinohrady

    Prague

  • Fakultni nemocnice v Motole

    Prague

Other trials in Czechia

Netherlands4 sites

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland

  • Leids Universitair Medisch Centrum

    Leiden

  • Maasstad Ziekenhuis

    Rotterdam, South Holland

  • ETZ-Elisabeth

    Tilburg

Other trials in Netherlands

Portugal4 sites

  • Unidade Local de Saúde de Matosinhos SA

    Matosinhos Municipality

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

    Porto, 4200-319

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto

Other trials in Portugal

Canada3 sites

  • Moncton Hospital

    Moncton, New Brunswick

  • CHUM Notre Dame Hospital

    Montreal, Quebec

  • CIUSSS-de-l'Est-de-l'Île-de-Montréal

    Montreal, Quebec

Other trials in Canada

Greece3 sites

  • Laiko General Hospital of Athens

    Athens, Attica

  • University General Hospital of Larissa

    Larissa

  • University General Hospital of Patras

    Pátrai, Achaïa

Other trials in Greece

Austria2 sites

  • Universitätsklinikum Innsbruck

    Innsbruck, Tyrol

  • Uniklinikum Salzburg

    Salzburg

Other trials in Austria

About this study

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)

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).

Being tested
Ibrutinib Oral Capsule, Placebo, Rituximab
Keywords
PCYC, Pharmacyclics, ibrutinib, rituximab, FL, Non-Hodgkin's Lymphoma, NHL
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibrutinib Oral CapsuleDrug

    Also called Imbruvica

    Ibrutinib 560mg administered orally daily

  • PlaceboDrug

    Placebo capsules to match ibrutinib administered orally daily

  • RituximabDrug

    Rituximab 375mg/m^2 intravenously (IV) weekly

Study groups in NCT02947347
Study groupRoleWhat they receive
(Arm A) ibrutinib + rituximabExperimentalParticipants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
Receives: Drug: Ibrutinib Oral Capsule; Drug: Rituximab
(Arm B) placebo + rituximabPlacebo comparatorParticipants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
Receives: Drug: Placebo; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) as Assessed by Investigator

    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.

    Measured: Primary Analysis cut-off; median overall follow-up of 53.75 months

Secondary outcomes (5)

  1. Overall Response Rate (ORR) as Assessed by Investigator

    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.

    Measured: Primary Analysis; median overall follow-up of 53.75 months

  2. Overall Survival (OS)

    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.

    Measured: Final Analysis; median overall follow-up of 58.97 months

  3. Infusion-related Reaction Rate Assessed by Investigator

    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.

    Measured: Primary Analysis; median overall follow-up of 53.75 months

  4. Duration of Response (DOR) as Assessed by Investigator

    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.

    Measured: Primary Analysis; median overall follow-up of 53.75 months

  5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Measured: Overall median treatment duration of 22.11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study start23 Jan 2017
  3. Primary completion21 Feb 2024
  4. Study completion9 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02947347
Sponsor's protocol ID
PCYC-1141-CA
Other IDs
2016-003202-14, 2023-507271-21-00, 2023, 2016
Status last verified
Feb 2026
First submitted
26 Oct 2016
Last updated
17 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Belada D, Gardner FP, de Oliveira AC, Sancho JM, Lomaia E, Wright D, Turgut M, Martynova E, Lazar Z, Anz B, Wang MC, Legiec W, Opat S, Pailden J, Peltier HM, Marturano E, Dean JP, Flinn IW. Phase 3 PERSPECTIVE study: Ibrutinib with rituximab for initial treatment of patients with follicular lymphoma. Hemasphere. 2026 Jun 17;10(6):e70400. doi: 10.1002/hem3.70400. eCollection 2026 Jun.

    PubMed 42317205

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib Oral Capsule and Rituximab in people with Follicular Lymphoma, run by Pharmacyclics LLC. at 128 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, Italy, Spain, Belgium, Turkey (Türkiye) and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Assessed by Investigator (time frame: Primary Analysis cut-off; median overall follow-up of 53.75 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02947347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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