AzTrials
AzTrials

Lymphoma, Mantle-CellPhase 3BRUIN-MCL-321NCT04662255

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

A Phase 3 study testing Pirtobrutinib, Ibrutinib and Acalabrutinib in people with Lymphoma, Mantle-Cell, run by Loxo Oncology, Inc. at 189 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Mantle-Cell
What is being tested?
Pirtobrutinib, Ibrutinib and Acalabrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
189 sitesin 24 countries
Study dates
8 Apr 2021to Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Confirmed MCL diagnosis
  • Previously treated with at least one prior line of systemic therapy for MCL
  • Measurable disease per Lugano criteria
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
  • Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
Show all 10Show fewer
  • Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
  • AST and ALT ≤ 3.0 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN.
  • Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

Who cannot join

  • Prior treatment with an approved or investigational BTK inhibitor
  • History of bleeding diathesis
  • History of stroke or intracranial hemorrhage within 6 months of randomization
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
  • Clinically significant cardiovascular disease
  • Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs
Show all 11Show fewer
  • Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
  • Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Vaccination with live vaccine within 28 days prior to randomization

Trial locations and contacts

189 sites in 24 countries.

189 sites in 24 countries

United States36 sites

  • Alaska Oncology and Hematology, LLC

    Anchorage, Alaska, 99508

  • Messino Cancer Center

    Asheville, North Carolina, 28806

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • DFCI Lymphoma

    Boston, Massachusetts, 02115

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45219

  • USO-Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Willamette Valley Cancer Institute & Research Ctr.

    Eugene, Oregon, 97401

  • USO-Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40504

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705-2254

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tulane Cancer Center Office of Clinical Research

    New Orleans, Louisiana, 70112

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Mercy Health-Paducah Medical Oncology and Hematology

    Paducah, Kentucky, 42003

  • Arizona Oncology Associates, P.C. - HOPE

    Phoenix, Arizona, 85013

  • Mayo Clinic

    Rochester, Minnesota, 55905-0002

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Texas Oncology - Sherman

    Sherman, Texas, 75090

  • Washington University Medical School

    St Louis, Missouri, 63110

  • Oncology-Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • US Oncology

    The Woodlands, Texas, 77380

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157-1045

Other trials in United States

China27 sites

  • Beijing ChaoYang Hospital

    Beijing, Beijing Municipality, 100020

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • Fujian Provincial Cancer Hospial

    Fuzhou, Fujian, 350014

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 233004

  • Lishui Central Hospital

    Lishui, Zhejiang, 323020

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Blood Institute of the Chinese Academy of Medical science

    Tianjin, 300020

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830002

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Brazil16 sites

  • Centro de Oncologia e Hematologia do Ceará LTDA

    Aldeota, Fortaliza, 60115-281

  • Centro de Pesquisa Clínica São Lucas

    Campinas, Sau Paulo, 13060-904

  • HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná

    Curitiba- PR, 80060 240

  • Hospital das Clínicas da UFGo - Goiânia

    Goiânia, Goiás, 74110-020

  • Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed

    Pacaembu, São Paulo, 01236-030

  • Hospital São Lucas Copacabana

    Rio de Janeiro, CEP, 22061-080

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, Rio de Jan, 20230-130

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto, Dept. CIP - Centro Integrado de Pesquisa

    Rio Preto, São Paulo, 15090-000

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, São Paulo, 09060-650

  • Hospital Sao Domingos

    São Luís, Maranhão, 65060-645

  • Hospital Beneficência Portuguesa de São Paulo

    São Paulo, CEP, 01321-001

  • A. C. Camargo Cancer Center

    São Paulo, São Paulo, 01509-900

  • IPITEC

    São Paulo, 01223-001

  • Hospital da Clinicas da Faculdade de Medicina da USP

    São Paulo, 05403-000

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

  • Hospital 9 De Julho

    São Paulo

Other trials in Brazil

Japan12 sites

  • Chugoku Central Hospital

    Hiroshima, 720-0001

  • Saitama Medical Center

    Kawagoe, Saitama, 350-8550

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto Furitsu Medical University Hospital

    Kyoto, 602-8566

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Okayama University Hospital

    Okayama, 700-8558

  • Kindai University Hospital

    Osaka Sayama-shi, Osaka, 589 8511

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

Other trials in Japan

France11 sites

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076

  • Hôpital Saint Vincent-de-Paul

    Lille, Hauts-de-France, 59020

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, 44093

  • Hopital de la Pitie Salpetriere

    Paris, Cedex 13, 75651

  • Institut Curie

    Paris, 75248

  • Centre hospitalier universitaire de Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Pole Regionalde Cancérologie(CHU de Poitiers)

    Politiers, Politiers, 86021

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

    Rouen, Seine-Maritime, 76038

  • CHRU De Tours

    Tours, 37044

  • Chu De Nancy Hop D'Adultes De Brabois

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca, Palma de Mallorca(Baleares), 07120

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Italy10 sites

  • Presidio Ospedaliero Civile Santi Antonio e Biagio

    Alessandria, AL, 15100

  • IRCCS - AOU di Bologna

    Bologna, 40138

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Ospedale Vincenzo Cervello

    Palermo, 90100

  • Irccs Crob

    Potenza, 85028

  • Ospedale Santa Maria delle Croci

    Ravenna, Emilia-Romagna, 48121

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, 21100

Other trials in Italy

Germany8 sites

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, Hesse, 35392

  • OncoResearch Lerchenfeld GmbH

    Hamburg, D-22081

  • InVO Institut für Versorgungsforschung in der Onkologie

    Koblenz, Rhineland-Palatinate, 56068

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

  • Klinikum der Universität München Großhadern

    Würzburg, Bavaria, 97080

Other trials in Germany

Taiwan8 sites

  • Chang Gung Memorial Hospital - Chiayi

    Chiayi County, 61363

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei City, Taipei, 114

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305

Other trials in Taiwan

United Kingdom7 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen City, AB25 2ZN

  • Beatson West of Scotland Cancer Centre

    Glasgow, G120YN

  • GenesisCare

    Newmarket, Suffolk, CB8 7XN

  • City Hospital, Nottingham University Hospitals

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH

  • GenesisCare, Windsor

    Windsor, SL4 3HD

Other trials in United Kingdom

Poland6 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Pratia MCM Krakow

    Krakow, 30-510

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, 93510

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, Lublin Voivodeship, 20-090

  • AIDPORT Sp. z o.o.

    Skorzewo, 60-185

  • Uniwersytecki Szpital Kliniczny Klinika

    Wroclaw, 50-367

Other trials in Poland

Australia5 sites

  • Icon Cancer Care - The Wesley Medical Centre

    Auchenflower, 4066

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • The St. George Hospital

    Kogarah, New South Wales, 2217

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

South Korea5 sites

  • Kosin University Gospel Hospital

    Busan, Seogu, 49267

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565

  • Seoul National University Hospital

    Seoul, Korea, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

Other trials in South Korea

Israel4 sites

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Belgium3 sites

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • AZ Delta

    Roeselare, West Flanders, 8800

Other trials in Belgium

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Netherlands3 sites

  • Bravis Ziekenhuis

    Bergen op Zoom, North Brabant, 4624 VT

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

  • Ziekenhuisapotheek HagaZiekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

Russia3 sites

  • GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin

    Moscow, 125101

  • Fed. State Budgetary Institution "Russian Scientific & Research Institute of Hemat. & Transfusiology of Fed. Medico-Bio. Agency

    Saint Petersburg, 191024

  • State Medical University named after I.P. Pavlov

    Saint Petersburg, 197022

Other trials in Russia

Austria2 sites

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020

  • Uniklinikum Salzburg

    Salzburg, Osterreich, 5020

Other trials in Austria

Czechia2 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05

Other trials in Czechia

Denmark2 sites

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus N, Jutland, 82000

  • Odense Universitetshospital

    Odense C, Syd, 5000

Other trials in Denmark

New Zealand2 sites

  • Christchurch Hospital

    Addington, Christchurch, 8011

  • Middlemore Clinical Trials

    Auckland, 2025

Other trials in New Zealand

Portugal2 sites

  • IPOFG - Lisboa

    Lisbon, 1099-035

  • Champalimaud Foundation

    Lisbon, 1400-038

Other trials in Portugal

Switzerland1 site

  • Kantonsspital Luzern

    Lucerne, Canton of Lucerne, 6000

Other trials in Switzerland

About this study

Official title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Read the detailed description

This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.

Being tested
Pirtobrutinib, Ibrutinib, Acalabrutinib, Zanubrutinib
Keywords
Bruton's Tyrosine Kinase Inhibitor, BTKi, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-Cell, Lymphoma, pirtobrutinib
Medical subject headings
Lymphoma, Mantle-Cell, Hematologic Diseases, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma

What participants receive

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

  • PirtobrutinibDrug

    Also called LOXO-305, LY3527727

    Oral

  • IbrutinibDrug

    Also called Imbruvica

    Oral

  • AcalabrutinibDrug

    Also called Calquence

    Oral

  • ZanubrutinibDrug

    Also called Brukinsa

    Oral

Study groups in NCT04662255
Study groupRoleWhat they receive
Arm A (Pirtobrutinib)ExperimentalOrally
Receives: Drug: Pirtobrutinib
Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)Active comparatorInvestigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.
Receives: Drug: Ibrutinib; Drug: Acalabrutinib; Drug: Zanubrutinib

What is being measured

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

  1. To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)

    Assessed per Lugano criteria

    Measured: Up to approximately 24 months

Secondary outcomes (7)

  1. To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

    Defined as the time from randomization to progressive disease (PD) or start of new treatment for MCL or withdrawal from trial due to toxicity or death

    Measured: Up to approximately 24 months

  2. To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

    Time from randomization to time when discontinuation criteria met

    Measured: Up to approximately 24 months

  3. Time to worsening (TTW) of MCL-related symptoms

    Using symptom questions identified from the European Organization for Research and Treatment of Cancer (EORTC) item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.

    Measured: Up to approximately 24 months

  4. Comparative Tolerability as measured by proportion of time with high side effect burden

    Using 18 items covering 10 Patient Reported Outcome- Common Terminology Criteria for Adverse Events (PRO-CTCAE) concepts for frequency (0-5 with 5 as most frequent), and/or presence (0-1 with 1 being present), or Severity (0-5 with 5 as most severe) and/or presence (0-1 with 1 being present); these selective adverse events will be framed and then overall side effect burden will be ascertained with the Functional Assessment of Cancer Therapy (FACT) - Item GP5. The range of this item is 0 -4 with 4 as most bothersome.

    Measured: Up to approximately 24 months

  5. To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

    Assessed per Lugano criteria

    Measured: Up to approximately 24 months

  6. To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

    Assessed per Lugano criteria

    Measured: Up to approximately 24 months

  7. To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms

    Assessed by survival

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted10 Dec 2020
  2. Study start8 Apr 2021
  3. Primary completionNov 2027 (estimated)
  4. Study completionJun 2030 (estimated)

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
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662255
Sponsor's protocol ID
18072
Other IDs
J2N-OX-JZNM, LOXO-BTK-20019
Acronym
BRUIN-MCL-321
Status last verified
Sep 2026
First submitted
4 Dec 2020
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • Loubert A, Creel K, Bhandari NR, Hess LM, Ruppert AS, Abada P, Regnault A, Payakachat N. Psychometric analysis of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library. J Patient Rep Outcomes. 2026 Jun 22;10(1):109. doi: 10.1186/s41687-026-01126-w.

    PubMed 42329537

  • Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15.

    PubMed 36377973

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pirtobrutinib, Ibrutinib and Acalabrutinib in people with Lymphoma, Mantle-Cell, run by Loxo Oncology, Inc. at 189 sites in 24 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 10 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, China, Brazil, Japan, France and 19 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL) (time frame: Up to approximately 24 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 NCT04662255, which also lists 2 linked publications.

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 23 Sep 2026.

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