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ID del estudio CA082-1215  |   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

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Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 40
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

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).

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Participant must be 18 years or older at the time of signing the informed consent form (ICF).
    1. Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology.
      1. 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.
        1. Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen.
          1. Prior to signing ICF, anti-cancer therapy for the treatment of PCNSL must only include standard of care regimens, with or without corticosteroids given for disease-related symptoms.
            1. Prior to ICF signature, participant's disease must be sensitive to prior high-dose methotrexate-based 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.
              1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
                1. Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.

                  Criterios de exclusión

                  Criterios de exclusión Icon
                  :
                  • Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.
                    1. Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL) and isolated cerebrospinal fluid (CSF) disease.
                      1. 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.
                        1. History of another primary malignancy that has not been in remission for ≥2 years.
                          1. Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology.
                            1. History of or active human immunodeficiency virus (HIV).
                              1. Active hepatitis B or active hepatitis C.
                                1. Active autoimmune disease requiring immunosuppressive therapy.
                                  Información Adicional *
                                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                                    Opciones de tratamiento

                                    Brazos del estudio

                                    INTERVENCIÓN ASIGNADA

                                    Brazos del estudio

                                    Experimental: Liso-cel Administration

                                    INTERVENCIÓN ASIGNADA
                                    • Drug: Rituximab, Methotrexate, Procarbazine, Temozolomide, Fludarabine, Cyclophosphamide, Calcium folinate
                                    • Biological: Liso-cel
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