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

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Rituximab
  • Methotrexate
  • Procarbazine
  • Temozolomide
  • Liso-cel
  • Fludarabine
  • Cyclophosphamide
  • Calcium folinate

Treatment groups

65 Participants
are divided into 1 treatment group

Locations

40
France
Local Institution - 011106202, NiceAlpes-Maritimes, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu44093 Cedex 1, NantesLoire-Atlantique, France
Local Institution - 010369495, Pierre-BéniteRhône, France
Local Institution - 010621079, Dijon France

Sponsors and collaborators

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

Lead sponsor