A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
- Conditions
- Relapsed/Refractory Follicular LymphomaMarginal Zone Lymphoma
- Interventions
- Registration Number
- NCT05100862
- Lead Sponsor
- BeiGene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 780
- Histologically confirmed grade 1-3a FL or MZL
- Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
- Need for systemic therapy for FL or MZL
- Measurable disease by computed tomography or magnetic resonance imaging
- Adequate bone marrow, liver and renal function
Key
- Transformation to aggressive lymphoma
- Requiring ongoing need for corticosteroid treatment
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years
- Active fungal, bacterial, and/or viral infection that requires systemic therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab Zanubrutinib Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab Obinutuzumab Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. Follicular Lymphoma Arm B: Lenalidomide plus Rituximab Rituximab Participants will receive lenalidomide and rituximab. Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab Zanubrutinib Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. Follicular Lymphoma Arm B: Lenalidomide plus Rituximab Lenalidomide Participants will receive lenalidomide and rituximab. Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab Rituximab Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab Rituximab Participants will receive lenalidomide and rituximab. Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab Lenalidomide Participants will receive lenalidomide and rituximab.
- Primary Outcome Measures
Name Time Method Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC) Approximately 78 months
- Secondary Outcome Measures
Name Time Method Time to Next Ant-Lymphoma Treatment Approximately 87 months Overall Survival Approximately 87 months Progression-free Survival As Determined By Investigator Assessment Approximately 87 months Overall Response Rate As Determined By BIRC And By Investigator Assessment Approximately 87 months Complete Response Rate As Determined By BIRC And By Investigator Assessment Approximately 87 months Time To Response As Determined By BIRC And By Investigator Assessment Approximately 87 months Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30) Approximately 87 months 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.
Duration Of Response As Determined By BIRC And By Investigator Assessment Approximately 87 months HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L) Approximately 87 months 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.
HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18) Approximately 87 months 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.
Number of Participants Experiencing Adverse Events (AEs) 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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Trial Locations
- Locations (289)
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
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
Memorial Cancer Institute, Memorial Healthcare System
🇺🇸Pembroke Pines, Florida, United States
Scroll for more (279 remaining)Ucsf Fresno University of California San Francisco Fresno🇺🇸Fresno, California, United States