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
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT07015242
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- 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 only include standard of care regimens, with or without corticosteroids given for disease-related symptoms.
- 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.
- 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.
- Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.
- Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL) and isolated cerebrospinal fluid (CSF) disease.
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liso-cel Administration Rituximab - Liso-cel Administration Methotrexate - Liso-cel Administration Procarbazine - Liso-cel Administration Temozolomide - Liso-cel Administration Liso-cel - Liso-cel Administration Fludarabine - Liso-cel Administration Cyclophosphamide - Liso-cel Administration Calcium folinate -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 12 months after liso-cel infusion Defined as the time from the date of liso-cel infusion to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method PFS 12 months after date of enrollment Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first
Modified Progression-free Survival (mPFS) 12 months after date of enrollment Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first. Disease relapse or progression prior to liso-cel infusion is considered as an event only if the patient does not achieve complete response (CR) after liso-cel infusion.
Complete Response Rate (CRR) Up to end of study (approximately 2 years) Defined as proportion of patients achieving CR at any time between liso-cel infusion and the date of first documented disease relapse or progression as assessed by the investigator, initiation of a new antineoplastic therapy to treat Primary Central Nervous System Lymphoma (PCNSL), or end of study, whichever occurs first
Overall Response Rate (ORR) Up to end of study (approximately 2 years) Defined as proportion of patients achieving CR or Partial Response (PR) at any time between liso-cel infusion and the date of first documented disease relapse or progression as assessed by the investigator, initiation of a new antineoplastic therapy to treat PCNSL, or end of study, whichever occurs first
Duration of Response (DoR) 12 months after liso-cel infusion Defined as the time from the date of first documented disease response (complete response \[CR\] or partial response \[PR\]) achieved after liso-cel infusion to the date of first subsequent documented disease relapse or progression as assessed by the investigator, or death from any cause
Event-free Survival (EFS) 12 months after date of enrollment Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or initiation of new antineoplastic therapy to treat PCNSL, or death from any cause, whichever occurs first
Overall Survival (OS) 12 months after date of enrollment Defined as the time from the date of enrollment to the date of death from any cause
Health-related quality of life (HRQoL) Up to end of study (approximately 2 years) As assessed by the European Organisation for Research and Treatment of Cancer--Quality of Life BN20 Questionnaire (EORTC-QLQ-BN20)
Trial Locations
- Locations (40)
Local Institution - 307
🇺🇸Stanford, California, United States
Local Institution - 305
🇺🇸Aurora, Colorado, United States
Local Institution - 308
🇺🇸Tampa, Florida, United States
Local Institution - 311
🇺🇸Chicago, Illinois, United States
Local Institution - 314
🇺🇸Boston, Massachusetts, United States
Local Institution - 313
🇺🇸Boston, Massachusetts, United States
Local Institution - 310
🇺🇸Buffalo, New York, United States
Local Institution - 301
🇺🇸New York, New York, United States
Local Institution - 302
🇺🇸Cleveland, Ohio, United States
Local Institution - 309
🇺🇸Columbus, Ohio, United States
Local Institution - 304
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 312
🇺🇸Nashville, Tennessee, United States
Local Institution - 303
🇺🇸Houston, Texas, United States
Local Institution - 306
🇺🇸Seattle, Washington, United States
Local Institution - 111
🇫🇷Nice, Alpes-Maritimes, France
Local Institution - 104
🇫🇷Nantes, Loire-Atlantique, France
Local Institution - 106
🇫🇷Dijon Cedex, France
Local Institution - 113
🇫🇷Lille, France
Local Institution - 112
🇫🇷Marseille cedex, France
Local Institution - 107
🇫🇷Montpellier, France
Local Institution - 114
🇫🇷Paris, France
Local Institution - 102
🇫🇷Paris, France
Local Institution - 108
🇫🇷Pessac, France
Local Institution - 103
🇫🇷Pierre Bénite, France
Local Institution - 101
🇫🇷Rennes Cedex 09, France
Local Institution - 105
🇫🇷Rouen Cedex, France
Local Institution - 110
🇫🇷Saint-Cloud, France
Local Institution - 115
🇫🇷Strasbourg, France
Local Institution - 109
🇫🇷Toulouse Cedex 9, France
Local Institution - 116
🇫🇷Vandoeuvre les Nancy, France
Local Institution - 205
🇩🇪Ulm, Baden-Württemberg, Germany
Local Institution - 206
🇩🇪Essen, Nordrhein-Westfalen, Germany
Local Institution - 204
🇩🇪Köln, Nordrhein-Westfalen, Germany
Local Institution - 208
🇩🇪Chemnitz, SN, Germany
Local Institution - 203
🇩🇪Berlin, Germany
Local Institution - 202
🇩🇪Freiburg, Germany
Local Institution - 207
🇩🇪Gottingen, Germany
Local Institution - 209
🇩🇪Hamburg, Germany
Local Institution - 210
🇩🇪Heidelberg, Germany
Local Institution - 201
🇩🇪Stuttgart, Germany