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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Rituximab
  Specified dose on specified days
• Препарат Methotrexate
  Specified dose on specified days
• Препарат Procarbazine
  Specified dose on specified days
• Препарат Temozolomide
  Specified dose on specified days
• Биопрепарат Liso-cel
  Specified dose on specified days
• Препарат Fludarabine
  Specified dose on specified days
• Препарат Cyclophosphamide
  Specified dose on specified days
• Препарат Calcium folinate
  Specified dose on specified days

Первичные конечные точки

• Progression-free Survival (PFS) [Срок оценки: 12 months after liso-cel infusion]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 16 центров

• 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
• … и ещё 8 центров

США · 14 центров

• 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
• … и ещё 6 центров

Германия · 10 центров

• 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
• … и ещё 2 центра

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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