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Mantle Cell LymphomaPhase 3NCT01776840

A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3 study testing Bendamustine, Rituximab and Ibrutinib in people with Mantle Cell Lymphoma, run by Janssen Research & Development, LLC at 201 sites in 28 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

The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Bendamustine, Rituximab and Ibrutinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
523 participants
Where
201 sitesin 28 countries
Study dates
16 May 2013to 24 Jun 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Diagnosis of mantle cell lymphoma (MCL) reviewed and approved by central laboratory: diagnosis must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5 and CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
  • Clinical Stage II, III, or IV by Ann Arbor Classification
  • At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
  • No prior therapies for MCL
  • Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
  • Hematology and biochemical laboratory values within protocol-defined limits
  • Agrees to protocol-defined use of effective contraception
  • Negative blood or urine pregnancy test at screening

Who cannot join

  • Major surgery within 4 weeks of random assignment
  • Known central nervous system lymphoma
  • Diagnosed or treated for malignancy other than MCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease
  • Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
  • History of stroke or intracranial hemorrhage within 6 months prior to random assignment
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Show all 11Show fewer
  • Requires treatment with strong CYP3A inhibitors
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Vaccinated with live, attenuated vaccines within 4 weeks of random assignment
  • Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk

Trial locations and contacts

201 sites in 28 countries.

201 sites in 28 countries

United States44 sites

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Study site

    Bismarck, North Dakota

  • Study site

    Burbank, California

  • Study site

    Burlington, Vermont

  • Study site

    Chicago, Illinois

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Eugene, Oregon

  • Study site

    Fargo, North Dakota

  • Study site

    Goshen, Indiana

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Hawthorne, New York

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Jefferson City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Louisville, Kentucky

  • Study site

    Maywood, Illinois

  • Study site

    Metairie, Louisiana

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Niles, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    San Antonio, Texas

  • Study site

    Sioux City, Iowa

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    Stamford, Connecticut

  • Study site

    Stanford, California

  • Study site

    Topeka, Kansas

  • Study site

    Tucson, Arizona

  • Study site

    Vancouver, Washington

  • Study site

    Watertown, South Dakota

  • Study site

    Westwood, Kansas

Other trials in United States

Russia14 sites

  • Study site

    Chelyabinsk

  • Study site

    Krasnodar

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Petrozavodsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Sochi

  • Study site

    St.Petersurg

  • Study site

    Syktyvkar

  • Study site

    Volgograd

  • Study site

    Yekaterinburg

Other trials in Russia

United Kingdom10 sites

  • Study site

    Canterbury

  • Study site

    Glasgow

  • Study site

    Leeds

  • Study site

    Leicester

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Plymouth

  • Study site

    Southampton

  • Study site

    Sutton

Other trials in United Kingdom

Israel9 sites

  • Study site

    Afula

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Nahariya

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

  • Study site

    Tsrifin

Other trials in Israel

Japan9 sites

  • Study site

    Fukuoka

  • Study site

    Hiroshima

  • Study site

    Kyoto

  • Study site

    Nagoya

  • Study site

    Osaka

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Suita

  • Study site

    Tokyo

Other trials in Japan

Australia8 sites

  • Study site

    Adelaide

  • Study site

    Auchenflower

  • Study site

    Box Hill

  • Study site

    Concord

  • Study site

    Douglas

  • Study site

    Gosford

  • Study site

    Hobart

  • Study site

    Prahran

Other trials in Australia

Germany8 sites

  • Study site

    Berlin

  • Study site

    Heidelberg

  • Study site

    Jena

  • Study site

    Mainz

  • Study site

    München

  • Study site

    TÿBINGEN

  • Study site

    Ulm

  • Study site

    Villingen-Schwenningen

Other trials in Germany

Belgium7 sites

  • Study site

    Antwerp

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Wilrijk

  • Study site

    Yvoir

Other trials in Belgium

France7 sites

  • Study site

    Créteil

  • Study site

    F-75 730 Paris Cedex 15

  • Study site

    Grenoble

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Tours

Other trials in France

Turkey (Türkiye)7 sites

  • Study site

    Adana

  • Study site

    Ankara

  • Study site

    Diyarbakır

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Kayseri

  • Study site

    Mersin

Other trials in Turkey (Türkiye)

Brazil6 sites

  • Study site

    Barretos

  • Study site

    Goiânia

  • Study site

    Porto Alegre

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

China6 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Shanghai

  • Study site

    Tianjin

Other trials in China

Netherlands6 sites

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Dordrecht

  • Study site

    Groningen

  • Study site

    Leiden

  • Study site

    Rotterdam

  • Study site

    Utrecht

Other trials in Netherlands

Spain6 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Oviedo

  • Study site

    Palma de Mallorca

  • Study site

    Salamanca

  • Study site

    Santiago de Compostela

Other trials in Spain

Taiwan6 sites

  • Study site

    Changhua

  • Study site

    Kaohsiung County

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Canada5 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Kaposvár

  • Study site

    Pécs

  • Study site

    Szeged

Other trials in Hungary

Poland5 sites

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Olsztyn

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Slovakia5 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Košice

  • Study site

    Martin

  • Study site

    Prešov

Other trials in Slovakia

Sweden5 sites

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Stockholm

  • Study site

    Umeaa

  • Study site

    Uppsala

Other trials in Sweden

Ukraine5 sites

  • Study site

    Cherkassy

  • Study site

    Donetsk

  • Study site

    Khmelnitskiy

  • Study site

    Kiev

  • Study site

    Lviv

Other trials in Ukraine

Argentina4 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    La Capital

  • Study site

    Paraná

Other trials in Argentina

Czechia3 sites

  • Study site

    Brno

  • Study site

    Hradec Králové

  • Study site

    Prague

Other trials in Czechia

Greece3 sites

  • Study site

    Athens

  • Study site

    Athens Attica

  • Study site

    Thessalonikis

Other trials in Greece

South Korea3 sites

  • Study site

    Gyeonggi-do

  • Study site

    Jeollanam-do

  • Study site

    Seoul

Other trials in South Korea

Ireland2 sites

  • Study site

    Dublin

  • Study site

    Galway

Other trials in Ireland

Mexico2 sites

  • Study site

    Monterrey

  • Study site

    Oaxaca City

Other trials in Mexico

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

Read the detailed description

This is a randomized (individuals assigned to study treatment by chance), double blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to compare the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab (BR) with BR alone in participants newly diagnosed with mantle cell lymphoma (MCL) who are 65 years of age or older. Approximately 520 participants will be randomly assigned in a 1:1 ratio and stratified by simplified Mantle Cell Lymphoma International Prognostic Index (MIPI) score (low risk [0-3] versus intermediate risk [4-5] versus high risk [6-11]). The treatment phase will extend from randomization until discontinuation of all study treatment or the clinical cutoff for the end of study. A cycle is defined as 28 days. All participants will receive open-label (identity of assigned study drug will be known) BR background therapy for a maximum of 6 cycles; participants with a complete response or partial response will continue to receive open-label background therapy with rituximab maintenance every second cycle for a maximum of 12 additional doses. In addition to the background therapy, all participants will receive blinded study drug (ibrutinib or placebo). Participants randomized to treatment Arm A will receive placebo capsules and participants randomized to treatment Arm B will receive ibrutinib capsules. Study drug will be administered daily and continuously until disease progression, unacceptable toxicity, or study end. Participants with stable disease after initial chemoimmunotherapy (BR+ibrutinib/placebo) should continue treatment with ibrutinib/placebo until disease progression, unacceptable toxicity, or study end. Participants with progressive disease must discontinue all study treatment. For participants who discontinue background therapy and do not have progressive disease, treatment with study drug will continue until disease progression or unacceptable toxicity or the clinical cutoff for the final analysis of progression-free survival (PFS). Participants receiving BR, rituximab, or ibrutinib at the clinical cutoff for the final analysis of PFS will continue open-label treatment until disease progression or unacceptable toxicity. Placebo will be stopped when the study is unblinded for the clinical cutoff for the final analysis of PFS. The posttreatment follow-up phase will begin once a participant discontinues bendamustine and rituximab and study drug. Participants who discontinue for reasons other than disease progression must continue to have disease evaluations as outlined in the protocol. Participants who discontinue due to disease progression will be followed for survival and subsequent anti-MCL therapy. The posttreatment follow-up phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. Four clinical cutoffs are planned. The first 3 clinical cutoffs will occur when approximately 134, 180, and 265 PFS events have been observed, respectively. The interim analyses and the final analysis of PFS will take place at these 3 clinical cutoffs, respectively; participant treatment assignment will be unblinded and placebo treatment will be stopped at the clinical cutoff for the final analysis of PFS. Treatment unblinding and stopping of placebo treatment could occur before the planned final analysis of PFS if recommended by the independent Data Monitoring Committee (DMC) after an interim analysis. The last cutoff will occur at the end of study, when 60% of the randomized participants have died or the Sponsor terminates the study, whichever comes first. Efficacy assessments will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. Safety will be monitored throughout the study and summarized. Blood samples will be drawn for assessment of pharmacokinetic parameters. Blood and bone marrow will be collected for assessment of minimal residual disease and biomarker studies.

Being tested
Bendamustine, Rituximab, Ibrutinib, Placebo
Keywords
Mantle cell lymphoma, Ibrutinib, Bruton's tyrosine kinase inhibitor, Bendamustine hydrochloride, Rituximab
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

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

  • BendamustineDrug

    90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6

  • RituximabDrug

    375 mg/m2 administered intravenously on Day 1, Cycles 1-6; if complete response or partial response is achieved, 375 mg/m2 is administered on Day 1 of every second cycle for a maximum of 12 additional doses

  • IbrutinibDrug

    560 mg (4 x 140 mg capsules) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end

  • PlaceboDrug

    4 capsules administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or the final analysis of progression-free survival

Study groups in NCT01776840
Study groupRoleWhat they receive
Treatment Arm APlacebo comparatorNot described
Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Placebo
Treatment Arm BExperimentalNot described
Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Ibrutinib

What is being measured

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

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) was defined as the interval between the date of randomization to the date of disease progression (PD) or relapse from complete response (CR) or death, whichever was first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD was defined as any new lesion or increase by 50 percent (%) of previously involved sites from nadir (PD criteria: Appearance of new nodal lesion 1.5 centimeters [cm] in any axis, 50% increase in sum of product of diameters [SPD] of greater than [>] 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis).

    Measured: Up to 97 months

Secondary outcomes (15)

  1. Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of the participant's death. Kaplan-Meier estimate was used.

    Measured: From randomization (Day -3) up to 121 months

  2. Complete Response Rate

    Complete response (CR) rate was defined as the percentage of participants who achieve CR (based on investigator assessment) on or prior to the initiation of subsequent anticancer therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on computed tomography (CT); spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.

    Measured: Up to 97 months

  3. Time-to-Next Treatment

    Time-to-next treatment was measured from the date of randomization to the start date of any anti-mantle cell lymphoma (anti-MCL) treatment subsequent to the study treatment.

    Measured: Up to 97 months

  4. Percentage of Participants With Overall Response

    Percentage of participants with overall response was defined as the portion of participants who achieved CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. Criteria for PR: greater than or equal to (>=) 50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.

    Measured: Up to 97 months

  5. Minimal Residual Disease (MRD)-Negative Response Rate

    Minimal residual disease negative rate was defined as the percentage of participants with a best overall response of CR with MRD-negative disease status (that is, <5 mantle cell lymphoma [MCL] cell per 10,000 leukocytes for detection using the MRD assay), as assessed by flow cytometry of a bone marrow and/or peripheral blood sample.

    Measured: Up to 97 months

  6. Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Questionnaire

    Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline, death, or a missing assessment due to being "too ill", whichever occurred first. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score was the total of reverse scores, ranged 0 to 60. Higher scores indicated a better quality of life.

    Measured: Up to 97 months

  7. Duration of Response (DoR)

    Duration of Response (DoR) was defined as the interval between the date of initial documentation of a response including PR and the date of first documented evidence of PD or death

    Measured: Up to 97 months

  8. Duration of Complete Response (DoCR)

    Duration of complete response (DoCR) was defined as the interval between the date of initial documentation of a CR and the date of first documented evidence of PD or death whichever occurs first.

    Measured: Up to 97 months

  9. Time to Response

    Time to response was defined as the interval between the date of randomization and the date of initial documentation of a response.

    Measured: Up to 97 months

  10. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Number of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication, or the initiation of subsequent anticancer therapy, whichever is earlier.

    Measured: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months

  11. Oral Plasma Clearance (CL/F) of Ibrutinib

    CL/F was defined as apparent total systemic clearance of ibrutinib after extravascular administration. Cl/F of Ibrutinib was determined using population pharmacokinetics (PopPK modeling).

    Measured: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

  12. Oral Volume of Distribution at Steady State of Ibrutinib

    Oral volume of distribution at steady state of ibrutinib was determined using PopPK modeling.

    Measured: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

  13. Area Under the Concentration Curve of Ibrutinib During 24 Hours After Dosing at Steady State

    Area under the concentration curve of ibrutinib during 24 hours after dosing at steady state was determined using PopPK modeling.

    Measured: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

  14. Minimum Observed Plasma Concentration of Ibrutinib

    Minimum observed plasma concentration of ibrutinib was determined using PopPK modeling.

    Measured: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

  15. Maximum Observed Plasma Concentration of Ibrutinib

    Maximum observed plasma concentration of ibrutinib was determined using PopPK modeling.

    Measured: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Timeline

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

  1. First posted28 Jan 2013 (estimated)
  2. Study start16 May 2013
  3. Primary completion30 Jun 2021
  4. Study completion24 Jun 2024

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
523 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01776840
Sponsor's protocol ID
CR100967
Other IDs
PCI-32765MCL3002, U1111-1137-0389, 2012-004056-11
Status last verified
Jun 2025
First submitted
24 Jan 2013
Last updated
8 Jul 2025
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Wang ML, Jurczak W, Jerkeman M, Trotman J, Zinzani PL, Belada D, Boccomini C, Flinn IW, Giri P, Goy A, Hamlin PA, Hermine O, Hernandez-Rivas JA, Hong X, Kim SJ, Lewis D, Mishima Y, Ozcan M, Perini GF, Pocock C, Song Y, Spurgeon SE, Storring JM, Walewski J, Zhu J, Qin R, Henninger T, Deshpande S, Howes A, Le Gouill S, Dreyling M; SHINE Investigators. Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma. N Engl J Med. 2022 Jun 30;386(26):2482-2494. doi: 10.1056/NEJMoa2201817. Epub 2022 Jun 3.

    PubMed 35657079

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bendamustine, Rituximab and Ibrutinib in people with Mantle Cell Lymphoma, run by Janssen Research & Development, LLC at 201 sites in 28 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 8 inclusion and 11 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 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Russia, United Kingdom, Israel, Japan and 23 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 26 Jul 2022). 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) (time frame: Up to 97 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 NCT01776840, 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 8 Jul 2025.

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