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Recruiting NCT07015242

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

Phase II Interventional Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rituximab, Methotrexate, Procarbazine, Temozolomide.
Who it may be relevant to
Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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

Primary outcome measures

  • Progression-free Survival (PFS) [Time frame: 12 months after liso-cel infusion]
Secondary outcome measures (12)
  • PFS [Time frame: 12 months after date of enrollment]
  • Modified Progression-free Survival (mPFS) [Time frame: 12 months after date of enrollment]
  • Complete Response Rate (CRR) [Time frame: Up to end of study (approximately 2 years)]
  • Overall Response Rate (ORR) [Time frame: Up to end of study (approximately 2 years)]
  • Duration of Response (DoR) [Time frame: 12 months after liso-cel infusion]
  • Event-free Survival (EFS) [Time frame: 12 months after date of enrollment]
  • Overall Survival (OS) [Time frame: 12 months after date of enrollment]
  • Number of participants with adverse events (AEs) [Time frame: Up to end of study (approximately 2 years)]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to end of study (approximately 2 years)]
  • Number of participants with adverse events of special interest (AESIs) [Time frame: Up to end of study (approximately 2 years)]
  • Number of participants with laboratory abnormalities [Time frame: Up to end of study (approximately 2 years)]
  • Health-related quality of life (HRQoL) [Time frame: Up to end of study (approximately 2 years)]

Eligibility criteria

Inclusion criteria

  • Participant must be 18 years or older at the time of signing the informed consent form (ICF).
  • Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology.
  • Transplant-ineligible based on physician's assessment and meeting at least one of the following criteria: age ≥65 years or HCT-CI (Hematopoietic Cell Transplantation-specific Comorbidity Index) score ≥3.
  • Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen.
  • Prior to signing ICF, anti-cancer therapy for the treatment of PCNSL must be limited to HD-MTX based standard of care regimens with a minimum of 4 and maximum of 6 doses of MTX. Corticosteroids used as part of standard-of-care management for PCNSL symptom control are permitted prior to ICF signature but must be discontinued at the time of ICF signature. For medical conditions other than PCNSL, non-therapeutic corticosteroids use may be permitted on study.
  • Prior to ICF enrollment, participant's disease must be sensitive to prior high-dose methotrexate-based (HD-MTX) regimens, as demonstrated by a complete response (CR, no remaining signs of PCNSL) or a partial response (PR, signs of PNCSL mostly gone) per Investigator's assessment, based on the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.

Exclusion criteria

  • Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.
  • Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL), isolated cerebrospinal fluid (CSF) disease, or a relapsed or refractory PCNSL.
  • Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she was to participate in the study based on investigator's judgement.
  • History of another primary malignancy that has not been in remission for ≥2 years.
  • Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology.
  • History of or active human immunodeficiency virus (HIV).
  • Active hepatitis B or active hepatitis C.
  • Active autoimmune disease requiring immunosuppressive therapy.
  • History of prior allogeneic transplant, or solid organ transplant requiring immunosuppressive therapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 16 centers
  • Local Institution - 0111 — Nice
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes
  • Local Institution - 0103 — Pierre-Bénite
  • CHU de Dijon Bourgogne - Hopital Francois Mitterand — Dijon
  • Chru De Lille - Hopital Claude Huriez — Lille
  • Local Institution - 0112 — Marseille
  • CHU Montpellier — Montpellier
  • Local Institution - 0114 — Paris
  • … and 8 more centers
United States · 14 centers
  • University Of Colorado — Aurora
  • Moffitt Cancer Center — Tampa
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
  • Dana-Farber Cancer Institute — Boston
  • Washington University School of Medicine in St. Louis — St Louis
  • Rutgers Cancer Institute of New Jersey — New Brunswick
  • Roswell Park Comprehensive Cancer Center — Buffalo
  • Memorial Sloan Kettering Cancer Center — New York
  • … and 6 more centers
Germany · 10 centers
  • Local Institution - 0202 — Freiburg im Breisgau
  • Universitätsklinikum Ulm — Ulm
  • Universitätsklinikum Köln — Cologne
  • Universitätsklinikum Essen — Essen
  • Klinikum Chemnitz gGmbH — Chemnitz
  • Charité - Universitätsmedizin Berlin — Berlin
  • Local Institution - 0207 — Göttingen
  • Universitätsklinikum Hamburg-Eppendorf — Hamburg
  • … and 2 more centers

Identifiers

NCT: NCT07015242 · CA082-1215 · 2025-521144-38 · U1111-1318-3732

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗