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ACTIVE NOT RECRUITING

NCT04662255

PHASE3

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

Sponsor: Loxo Oncology, Inc.

View on ClinicalTrials.gov

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). Participation could last up to two years, and possibly longer, if the disease does not progress.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2021-04-08

Completion Date

2028-04

Last Updated

2025-05-28

Healthy Volunteers

Conditions

Lymphoma, Mantle-Cell

Interventions

DRUG

Pirtobrutinib

Oral

DRUG

Ibrutinib

Oral

DRUG

Acalabrutinib

Oral

DRUG

Zanubrutinib

Oral

Locations (189)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States

Arizona Oncology Associates, P.C. - HOPE

Phoenix, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

USO-Rocky Mountain Cancer Center

Denver, Colorado, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Oncology-Hematology Associates of West Broward

Tamarac, Florida, United States

Florida Cancer Specialists East

West Palm Beach, Florida, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Mercy Health-Paducah Medical Oncology and Hematology

Paducah, Kentucky, United States

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana, United States

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

DFCI Lymphoma

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University Medical School

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Messino Cancer Center

Asheville, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Willamette Valley Cancer Institute & Research Ctr.

Eugene, Oregon, United States

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, United States

Texas Oncology-Austin Midtown

Austin, Texas, United States

Texas Oncology - Bedford

Bedford, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - McAllen

McAllen, Texas, United States

Texas Oncology - Sherman

Sherman, Texas, United States

US Oncology

The Woodlands, Texas, United States

Texas Oncology - Tyler

Tyler, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

The St. George Hospital

Kogarah, New South Wales, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Icon Cancer Care - The Wesley Medical Centre

Auchenflower, Australia

Uniklinikum Salzburg

Salzburg, Osterreich, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

AZ Delta

Roeselare, West Flanders, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

Hospital São Lucas Copacabana

Rio de Janeiro, CEP, Brazil

Hospital Beneficência Portuguesa de São Paulo

São Paulo, CEP, Brazil

Centro de Oncologia e Hematologia do Ceará LTDA

Aldeota, Fortaliza, Brazil

Hospital das Clínicas da UFGo - Goiânia

Goiânia, Goiás, Brazil

Hospital Sao Domingos

São Luís, Maranhão, Brazil

Instituto Nacional de Câncer - INCA

Rio de Janeiro, Rio de Jan, Brazil

Centro de Pesquisa Clínica São Lucas

Campinas, Sau Paulo, Brazil

Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed

Pacaembu, São Paulo, Brazil

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

Rio Preto, São Paulo, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, Brazil

A. C. Camargo Cancer Center

São Paulo, São Paulo, Brazil

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

Curitiba- PR, Brazil

IPITEC

São Paulo, Brazil

Hospital da Clinicas da Faculdade de Medicina da USP

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Hospital 9 De Julho

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Beijing ChaoYang Hospital