Mantle Cell Lymphoma
Conditions
Brief summary
The primary endpoint is PFS as determined by independent central review using the Lugano Classification for NHL and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
Detailed description
Progression-free survival as determined by investigator assessment using the Lugano Classification for NHL, and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first, Overall response rate, defined as the proportion of patients who achieve a CR or partial response (PR), determined by independent central review and by investigator assessment, Duration of response, as determined by independent central review and by investigator assessment, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first, Overall survival, defined as the time from randomization to the date of death due to any reason, Rate of CR or complete metabolic response, defined as the proportion of patients who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment, Time to response, as determined by independent central review and by investigator assessment, and defined as time from randomization to the first documentation of response, Patient-reported outcomes as measured by the EQ-5D-5L and EORTC QLQ-C30 questionnaires, Safety parameters, including AEs, SAEs, clinical laboratory tests, physical exams, and vital signs
Interventions
DRUGMabThera 500 mg concentrate for solution for infusion
DRUGZanubrutinib
DRUGBendamustin Kabi 2
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is PFS as determined by independent central review using the Lugano Classification for NHL and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival as determined by investigator assessment using the Lugano Classification for NHL, and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first, Overall response rate, defined as the proportion of patients who achieve a CR or partial response (PR), determined by independent central review and by investigator assessment, Duration of response, as determined by independent central review and by investigator assessment, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first, Overall survival, defined as the time from randomization to the date of death due to any reason, Rate of CR or complete metabolic response, defined as the proportion of patients who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment, Time to re | — |
Countries
Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed