The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
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
799
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.
Ucsf Fresno University of California San Francisco Fresno
Fresno, California, United States
Kaiser Permanente Southern California
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Time frame: Approximately 78 months
Progression-free Survival As Determined By Investigator Assessment
Time frame: Approximately 87 months
Duration Of Response As Determined By BIRC And By Investigator Assessment
Time frame: Approximately 87 months
Overall Response Rate As Determined By BIRC And By Investigator Assessment
Time frame: Approximately 87 months
Complete Response Rate As Determined By BIRC And By Investigator Assessment
Time frame: Approximately 87 months
Time To Response As Determined By BIRC And By Investigator Assessment
Time frame: Approximately 87 months
Time to Next Ant-Lymphoma Treatment
Time frame: Approximately 87 months
Overall Survival
Time frame: Approximately 87 months
Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30)
HRQ0L assessed by The European Organization For Research On Treatment Of Cancer Quality Of Life Questionnaire-core 30 (EORTC QLQ-C30) consists of 30 questions that are associated with 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single symptom items ( dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scores range from 0 to 100 and higher score indicates better quality of life.
Time frame: Approximately 87 months
HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L)
The EQ-5D-5L is comprised of a descriptive module and a visual analogue scale. The EQ-5D-5L descriptive module comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the respondent's self-rated health on a 0 to 100 scale, with 100 labeled "the best health you can imagine" and 0 labeled "the worst health you can imagine. Higher scores indicate better quality of life.
Time frame: Approximately 87 months
HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18)
The FLymSI-18 is comprised of 18 questions which cover 4 sub-scales: physical symptoms, emotional symptoms, side effects, and functional well-being. Scores are based on the 5-level Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. Higher score indicates better quality of life.
Time frame: Approximately 87 months
Number of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose to 28 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of obinutuzumab or rituximab, or until the date of confirmed disease progression, whichever comes later (Approximately 87 months)
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UCLA Hematologyoncology
Los Angeles, California, United States
Scripps Health
San Diego, California, United States
Sharp Healthcare Sharp Memorial Hospital
San Diego, California, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
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