This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
510
Administered as two 80 mg capsules by mouth twice a day
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Progression-free survival (PFS) determined by independent central review
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
Time frame: Up to approximately 7 years
PFS by investigator assessment
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
Time frame: Up to approximately 7 years
Overall response rate (ORR)
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), determined by independent central review and by investigator assessment.
Time frame: Up to approximately 7 years
Duration of response (DOR)
DOR, 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.
Time frame: Up to approximately 7 years
Overall survival (OS)
OS is defined as the time from randomization to the date of death due to any reason.
Time frame: Up to approximately 7 years
Time to Response (TTR)
TTR, as determined by independent central review and by investigator assessment, and defined as the time from randomization to the first documentation of response.
Time frame: Up to approximately 7 years
Rate of complete response (CR) or complete metabolic response
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Chao Family Comprehensive Cancer Center
Orange, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
...and 166 more locations
Rate of CR or complete metabolic response is defined as the percentage of participants who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment.
Time frame: Up to approximately 7 years
Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L)
EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system involves five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants may choose from the following response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.
Time frame: Up to approximately 7 years
PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
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: Up to approximately 7 years
Number of participants with adverse events and serious adverse events
Number of participants with adverse events and serious adverse events, including laboratory values, vital signs, and physical examination findings.
Time frame: Up to approximately 7 years