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RECRUITING
NCT07015242
PHASE2

A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).

Official title: The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2025-11-06

Completion Date

2028-12-10

Last Updated

2026-07-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rituximab

Specified dose on specified days

DRUG

Methotrexate

Specified dose on specified days

DRUG

Procarbazine

Specified dose on specified days

DRUG

Temozolomide

Specified dose on specified days

BIOLOGICAL

Liso-cel

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

DRUG

Calcium folinate

Specified dose on specified days

Locations (40)

University Of Colorado

Aurora, Colorado, United States

Moffitt Cancer Center

Tampa, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Local Institution - 0111

Nice, Alpes-Maritimes, France

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

Nantes, Loire-Atlantique, France

Local Institution - 0103

Pierre-Bénite, Rhône, France

Local Institution - 0106

Dijon, France

Chru De Lille - Hopital Claude Huriez

Lille, France

Local Institution - 0112

Marseille, France

CHU Montpellier

Montpellier, France

Local Institution - 0114

Paris, France

Local Institution - 0102

Paris, France

Local Institution - 0108

Pessac, France

CHU de Rennes - Hopital de Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

Local Institution - 0110

Saint-Cloud, France

Local Institution - 0115

Strasbourg, France

Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

Toulouse, France

Local Institution - 0116

Vandœuvre-lès-Nancy, France

Local Institution - 0202

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Local Institution - 0207

Göttingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Klinikum Stuttgart - Katharinenhospital

Stuttgart, Germany