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Study of BTK Inhibitor LOXO-3...

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

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma, Mantle-Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (Pirtobrutinib)

Orally

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Oral

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.

Group Type ACTIVE_COMPARATOR

Ibrutinib

Intervention Type DRUG

Oral

Acalabrutinib

Intervention Type DRUG

Oral

Zanubrutinib

Intervention Type DRUG

Oral

Interventions

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Pirtobrutinib

Oral

Intervention Type DRUG

Ibrutinib

Oral

Intervention Type DRUG

Acalabrutinib

Oral

Intervention Type DRUG

Zanubrutinib

Oral

Intervention Type DRUG

Other Intervention Names

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LOXO-305 LY3527727 Imbruvica Calquence Brukinsa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patient Advocacy

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

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Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States

Site Status

Arizona Oncology Associates, P.C. - HOPE

Phoenix, Arizona, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

USO-Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Oncology-Hematology Associates of West Broward

Tamarac, Florida, United States

Site Status

Florida Cancer Specialists East

West Palm Beach, Florida, United States

Site Status

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Mercy Health-Paducah Medical Oncology and Hematology

Paducah, Kentucky, United States

Site Status

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana, United States

Site Status

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

DFCI Lymphoma

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University Medical School

St Louis, Missouri, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Messino Cancer Center

Asheville, North Carolina, United States

Site Status

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Site Status

Willamette Valley Cancer Institute & Research Ctr.

Eugene, Oregon, United States

Site Status

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, United States

Site Status

Texas Oncology-Austin Midtown

Austin, Texas, United States

Site Status

Texas Oncology - Bedford

Bedford, Texas, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Texas Oncology - McAllen

McAllen, Texas, United States

Site Status

Texas Oncology - Sherman

Sherman, Texas, United States

Site Status

US Oncology

The Woodlands, Texas, United States

Site Status

Texas Oncology - Tyler

Tyler, Texas, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Site Status

The St. George Hospital

Kogarah, New South Wales, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Icon Cancer Care - The Wesley Medical Centre

Auchenflower, , Australia

Site Status

Uniklinikum Salzburg

Salzburg, Osterreich, Austria

Site Status

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Site Status

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status

AZ Delta

Roeselare, West Flanders, Belgium

Site Status

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

Hospital São Lucas Copacabana

Rio de Janeiro, CEP, Brazil

Site Status

Hospital Beneficência Portuguesa de São Paulo

São Paulo, CEP, Brazil

Site Status

Centro de Oncologia e Hematologia do Ceará LTDA

Aldeota, Fortaliza, Brazil

Site Status

Hospital das Clínicas da UFGo - Goiânia

Goiânia, Goiás, Brazil

Site Status

Hospital Sao Domingos

São Luís, Maranhão, Brazil

Site Status

Instituto Nacional de Câncer - INCA

Rio de Janeiro, Rio de Jan, Brazil

Site Status

Centro de Pesquisa Clínica São Lucas

Campinas, Sau Paulo, Brazil

Site Status

Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed

Pacaembu, São Paulo, Brazil

Site Status

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

Rio Preto, São Paulo, Brazil

Site Status

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, Brazil

Site Status

A. C. Camargo Cancer Center

São Paulo, São Paulo, Brazil

Site Status

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

Curitiba- PR, , Brazil

Site Status

IPITEC

São Paulo, , Brazil

Site Status

Hospital da Clinicas da Faculdade de Medicina da USP

São Paulo, , Brazil

Site Status

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, , Brazil

Site Status

Hospital 9 De Julho

São Paulo, , Brazil

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Site Status

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status