A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

Overall Survival (OS)

OS is defined as the time from randomization to the date of death from any cause.

Time frame: Approximately 92 months

PFS as assessed by investigator (INV)

PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

Time frame: Approximately 58 months

Overall Response Rate (ORR) as assessed by BIRC and by INV

ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR), per Lugano 2014 criteria.

Time frame: Approximately 58 months

Duration of Response (DOR) as assessed by BIRC and by INV

DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first.

Time frame: Approximately 58 months

Complete Response Rate (CRR) as assessed by BIRC and by INV

CRR is defined as the percentage of participants who achieved a best overall response of CR.

Time frame: Approximately 58 months

Time to first response as assessed by BIRC and by INV

Time to first response is defined as time from the date of randomization to first response.

Time frame: Approximately 58 months

Time to initiation of new anticancer therapy

Time to initiation of new anticancer therapy is defined as time from the date of randomization to the date of initiation of new anticancer therapy.

Time frame: Approximately 58 months

Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)

Patient-reported symptom burden, neuropathy, and physical condition/fatigue as measured by the EORTC-QLQ-NHL-HG29 questionnaire. The EORTC-QLQ-NHL-HG29 is the NHL-aggressive module of QLQ-C30; and it consists of 5 scales: Symptom burden due to disease and/or treatment (7 items), Neuropathy (2 items), Physical condition/Fatigue (5 items), Emotional impacts (4 items), and Worries/Fears health and functioning (11 items). Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). A higher score for all the multi-item scales and items represents a higher level of symptomatology or problems.

Time frame: Approximately 58 months

Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

Patient-reported global health status (GHS), role, and physical function as measured by the EORTC-QLQ-C30 questionnaire. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).

Time frame: Approximately 58 months

Number of participants with treatment-emergent adverse events (TEAEs)

Number of participants with TEAEs, including laboratory values, vital signs, electrocardiogram results, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months