relapsed or refractory mantle cell lymphoma (R/R MCL)
Conditions
Brief summary
Progression-free survival (PFS), as assessed by blinded independent review committee (BIRC), defined as the time from randomization to the date of progression or death, whichever occurs first.
Detailed description
Overall survival (OS), defined as the time from randomization to the date of death from any cause., Progression-free survival (PFS) as determined by investigator., Overall response rate (ORR) as determined by BIRC and by investigator per the Lugano 2014 criteria. ORR is defined as the proportion of patients who achieved a best overall response of partial response or complete response (CR)., Duration of response (DOR) as determined by BIRC and by investigator. It is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first., Complete response rate (CRR), as determined by BIRC and by investigator. It is defined as the proportion of patients who achieved a best overall response of CR., Time to first response as determined by BIRC and by investigator. It is defined as time from randomization to first response., Time to initiation of new anticancer therapy., Patient-reported symptom burden and physical condition/fatigue as measured 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) questionnaire, and global health status (GHS) and physical function as measured by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)., Incidence and severity of treatment-emergent adverse events (TEAE)s graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Interventions
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), as assessed by blinded independent review committee (BIRC), defined as the time from randomization to the date of progression or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time from randomization to the date of death from any cause., Progression-free survival (PFS) as determined by investigator., Overall response rate (ORR) as determined by BIRC and by investigator per the Lugano 2014 criteria. ORR is defined as the proportion of patients who achieved a best overall response of partial response or complete response (CR)., Duration of response (DOR) as determined by BIRC and by investigator. It is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first., Complete response rate (CRR), as determined by BIRC and by investigator. It is defined as the proportion of patients who achieved a best overall response of CR., Time to first response as determined by BIRC and by investigator. It is defined as time from randomization to first response., Time to initiation of new anticancer therapy., Patient-reported symptom burden and physical condition/fatigue as measured by | — |
Countries
Austria, France, Germany, Italy, Poland, Spain
Outcome results
None listed