Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321)

May 13, 2026 updated by: Loxo Oncology, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
        • Icon Cancer Care - The Wesley Medical Centre
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • The St. George Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
    • Osterreich
      • Salzburg, Osterreich, Austria, 5020
        • Uniklinikum Salzburg
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen
  • Belgium
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • West Flanders
      • Roeselare, West Flanders, Belgium, 8800
        • AZ Delta
  • Brazil
      • Curitiba- PR, Brazil, 80060 240
        • HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná
      • São Paulo, Brazil, 05403-000
        • Hospital da Clinicas da Faculdade de Medicina da USP
      • São Paulo, Brazil, 05652-900
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo, Brazil
        • Hospital 9 De Julho
      • São Paulo, Brazil, 01223-001
        • IPITEC
    • CEP
      • Rio de Janeiro, CEP, Brazil, 22061-080
        • Hospital São Lucas Copacabana
      • São Paulo, CEP, Brazil, 01321-001
        • Hospital Beneficência Portuguesa de São Paulo
    • Fortaliza
      • Aldeota, Fortaliza, Brazil, 60115-281
        • Centro de Oncologia e Hematologia do Ceará LTDA
    • Goiás
      • Goiânia, Goiás, Brazil, 74110-020
        • Hospital das Clínicas da UFGo - Goiânia
    • Maranhão
      • São Luís, Maranhão, Brazil, 65060-645
        • Hospital Sao Domingos
    • Rio de Jan
      • Rio de Janeiro, Rio de Jan, Brazil, 20230-130
        • Instituto Nacional de Cancer - INCa
    • Sau Paulo
      • Campinas, Sau Paulo, Brazil, 13060-904
        • Centro de Pesquisa Clínica São Lucas
    • São Paulo
      • Pacaembu, São Paulo, Brazil, 01236-030
        • Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed
      • Rio Preto, São Paulo, Brazil, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto, Dept. CIP - Centro Integrado de Pesquisa
      • Santo André, São Paulo, Brazil, 09060-650
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
      • São Paulo, São Paulo, Brazil, 01509-900
        • A. C. Camargo Cancer Center
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Cancer Care Manitoba
  • China
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Tianjin, China, 300020
        • Blood Institute of the Chinese Academy of Medical science
    • Anhui
      • Hefei, Anhui, China, 233004
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100020
        • Beijing Chaoyang Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospial
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital
      • Guangzhou, Guangdong, China, 510000
        • Cancer Center of Guangzhou Medical University
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
      • Yichang, Hubei, China, 443003
        • Yichang Central People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of NanChang University
    • Jilin
      • Changchun, Jilin, China, 130000
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital Of China Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830002
        • Affiliated Tumor Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Lishui, Zhejiang, China, 323020
        • Lishui Central Hospital
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Denmark
    • Jutland
      • Aarhus N, Jutland, Denmark, 82000
        • Aarhus Universitetshospital, Aarhus Sygehus
    • Syd
      • Odense C, Syd, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
      • Paris, France, 75248
        • Institut Curie
      • Pessac, France, 33604
        • Centre hospitalier universitaire de Haut Leveque
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Tours, France, 37044
        • CHRU de Tours
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
    • Cedex 13
      • Paris, Cedex 13, France, 75651
        • Hopital de la Pitie Salpetriere
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59020
        • Hôpital Saint Vincent-De-Paul
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Chu De Nancy Hop D'Adultes De Brabois
    • Politiers
      • Politiers, Politiers, France, 86021
        • Pole Regionalde Cancérologie(CHU de Poitiers)
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
  • Germany
      • Hamburg, Germany, D-22081
        • OncoResearch Lerchenfeld GmbH
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89075
        • Universitatsklinikum Ulm
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Klinikum der Universität München Großhadern
    • Hesse
      • Giessen, Hesse, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitätsklinikum Münster - Albert Schweitzer Campus
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56068
        • InVO Institut für Versorgungsforschung in der Onkologie
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitätsmedizin Johannes Gutenberg Universität Mainz
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
  • Israel
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • IRCCS - AOU di Bologna
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Palermo, Italy, 90100
        • Ospedale Vincenzo Cervello
      • Potenza, Italy, 85028
        • Irccs Crob
      • Reggio Emilia, Italy, 42123
        • Arcispedale Santa Maria Nuova
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
    • AL
      • Alessandria, AL, Italy, 15100
        • Presidio Ospedaliero Civile Santi Antonio e Biagio
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Ravenna, Emilia-Romagna, Italy, 48121
        • Ospedale Santa Maria delle Croci
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele
  • Japan
      • Hiroshima, Japan, 720-0001
        • Chugoku Central Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 602-8566
        • Kyoto Furitsu Medical University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Nagoya Medical Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Osaka
      • Osaka Sayama-shi, Osaka, Japan, 589 8511
        • Kindai University Hospital
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Saitama Medical Center
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
      • The Hague, Netherlands, 2545 AA
        • Ziekenhuisapotheek HagaZiekenhuis
    • North Brabant
      • Bergen op Zoom, North Brabant, Netherlands, 4624 VT
        • Bravis ziekenhuis
  • New Zealand
      • Auckland, New Zealand, 2025
        • Middlemore Clinical Trials
    • Christchurch
      • Addington, Christchurch, New Zealand, 8011
        • Christchurch Hospital
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 30-510
        • Pratia MCM Krakow
      • Lodz, Poland, 93510
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
      • Skorzewo, Poland, 60-185
        • AIDPORT Sp. z o.o.
      • Wroclaw, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
  • Portugal
      • Lisbon, Portugal, 1400-038
        • Champalimaud Foundation
      • Lisbon, Portugal, 1099-035
        • IPOFG - Lisboa
  • Russia
      • Moscow, Russia, 125101
        • GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin
      • Saint Petersburg, Russia, 191024
        • Fed. State Budgetary Institution "Russian Scientific & Research Institute of Hemat. & Transfusiology of Fed. Medico-Bio. Agency
      • Saint Petersburg, Russia, 197022
        • State Medical University named after I.P. Pavlov
  • South Korea
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea, 21565
        • Gachon University Gil Medical Center
    • Korea
      • Seoul, Korea, South Korea, 03080
        • Seoul National University Hospital
    • Seogu
      • Busan, Seogu, South Korea, 49267
        • Kosin University Gospel Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Asan Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Hospital Universitari Vall d'Hebron
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
    • Palma de Mallorca(Baleares)
      • Palma de Mallorca, Palma de Mallorca(Baleares), Spain, 07120
        • Hospital Universitario Son Espases
  • Switzerland
    • Canton of Lucerne
      • Lucerne, Canton of Lucerne, Switzerland, 6000
        • Kantonsspital Luzern
  • Taiwan
      • Chiayi County, Taiwan, 61363
        • Chang Gung Memorial Hospital - Chiayi
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng-Kung Uni. Hosp.
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Memorial Hospital - Linkou
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Tri-Service General Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G120YN
        • Beatson West Of Scotland Cancer Centre
      • Nottingham, United Kingdom, NG5 1PB
        • City Hospital, Nottingham University Hospitals
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
      • Windsor, United Kingdom, SL4 3HD
        • GenesisCare, Windsor
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital
    • Suffolk
      • Newmarket, Suffolk, United Kingdom, CB8 7XN
        • GenesisCare
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology, Llc
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Arizona Oncology Associates, P.C. - HOPE
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • USO-Rocky Mountain Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
      • Tamarac, Florida, United States, 33321
        • Oncology-Hematology Associates of West Broward
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists East
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky Markey Cancer Center
      • Paducah, Kentucky, United States, 42003
        • Mercy Health-Paducah Medical Oncology and Hematology
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Cancer Center Office of Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • DFCI Lymphoma
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0002
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University Medical School
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Messino Cancer Center
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Winston-Salem, North Carolina, United States, 27157-1045
        • Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Oncology Hematology Care Inc
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute & Research Ctr.
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute SCRI
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology-Austin Midtown
      • Bedford, Texas, United States, 76022
        • Texas Oncology - Bedford
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
      • The Woodlands, Texas, United States, 77380
        • US Oncology
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
      • Fairfax, Virginia, United States, 22031
        • USO-Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2254
        • University of Wisconsin Carbone Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A (Pirtobrutinib)
Orally
Drug: Pirtobrutinib
Oral
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)
Investigator'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.
Drug: Acalabrutinib
Oral
Other Names:
  • Calquence
Drug: Ibrutinib
Oral
Other Names:
  • Imbruvica
Drug: Zanubrutinib
Oral
Other Names:
  • Brukinsa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Assessed per Lugano criteria
Up to approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
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
Up to approximately 24 months
To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Time from randomization to time when discontinuation criteria met
Up to approximately 24 months
Time to worsening (TTW) of MCL-related symptoms
Time Frame: Up to approximately 24 months
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.
Up to approximately 24 months
Comparative Tolerability as measured by proportion of time with high side effect burden
Time Frame: Up to approximately 24 months
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.
Up to approximately 24 months
To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Assessed per Lugano criteria
Up to approximately 24 months
To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Assessed per Lugano criteria
Up to approximately 24 months
To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Assessed by survival
Up to approximately 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loxo Oncology, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Patient Advocacy, Loxo Oncology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18072
  • LOXO-BTK-20019 (Other Identifier: Eli Lilly and Company)
  • J2N-OX-JZNM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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