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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression-free Survival (PFS)
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
Time frame: 12 months after liso-cel infusion
PFS
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
Time frame: 12 months after date of enrollment
Modified Progression-free Survival (mPFS)
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.
Time frame: 12 months after date of enrollment
Complete Response Rate (CRR)
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
Time frame: Up to end of study (approximately 2 years)
Overall Response Rate (ORR)
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
Time frame: Up to end of study (approximately 2 years)
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 307
Stanford, California, United States
WITHDRAWNLocal Institution - 0305
Aurora, Colorado, United States
NOT_YET_RECRUITINGLocal Institution - 305
Aurora, Colorado, United States
WITHDRAWNLocal Institution - 308
Tampa, Florida, United States
WITHDRAWNMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGLocal Institution - 0311
Chicago, Illinois, United States
NOT_YET_RECRUITINGLocal Institution - 311
Chicago, Illinois, United States
WITHDRAWNLocal Institution - 314
Boston, Massachusetts, United States
WITHDRAWNDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGLocal Institution - 313
Boston, Massachusetts, United States
WITHDRAWN...and 72 more locations
Duration of Response (DoR)
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
Time frame: 12 months after liso-cel infusion
Event-free Survival (EFS)
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
Time frame: 12 months after date of enrollment
Overall Survival (OS)
Defined as the time from the date of enrollment to the date of death from any cause
Time frame: 12 months after date of enrollment
Health-related quality of life (HRQoL)
As assessed by the European Organisation for Research and Treatment of Cancer--Quality of Life C30 Questionnaire (EORTC-QLQ-30)
Time frame: Up to end of study (approximately 2 years)
Health-related quality of life (HRQoL)
As assessed by the European Organisation for Research and Treatment of Cancer--Quality of Life BN20 Questionnaire (EORTC-QLQ-BN20)
Time frame: Up to end of study (approximately 2 years)