Mantle Cell Lymphoma MedDRA version: 20.0 Level: PT Classification code 10061275 Term: Mantle cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
BeiGene, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • = 70 years of age at the time of informed consent, OR • 60 and =65 years) yes F.1.3.1 Number of subjects for this age range 475
Exclusion criteria
Exclusion criteria: • Known central nervous system involvement by lymphoma • Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant • Clinically significant cardiovascular disease • History of severe bleeding disorder • Unable to swallow capsules or disease significantly affecting gastrointestinal function • Active fungal, bacterial and/or viral infection requiring systemic therapy • Requires ongoing treatment with a strong CYP3A inhibitor or inducer Please refer to the protocol for a full list of the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy, as measured by progression-free survival (PFS) determined by independent central review;Secondary Objective: Secondary: • To evaluate efficacy, as measured by the following: - Progression-free survival determined by investigator assessment - Overall response rate (ORR), as determined by independent central review and by investigator assessment - Duration of response (DOR), as determined by independent central review and by investigator assessment - Overall survival (OS) - Rate of complete response (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 - Patient reported outcomes • To evaluate safety and tolerability ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: date of first documentation of disease progression or death, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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;Timepoint(s) of evaluation of this end point: all of the secondary endpoints except last two have defined timepoints included above. In an addition PRO's are measured at every visit during treatment. Safety parameters are measured at every visit. Adverse events will be reported until 30 days after the last dose of zanubrutinib or bendamustine, or until 90 days after the last dose of rituximab, whichever occurs later. | — |
Countries
Australia, Austria, Belgium, Canada, China, France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactUS
BeiGene, Ltd.
Outcome results
None listed