follicular lymphoma, marginal zone lymphoma
Conditions
Brief summary
R/R FL cohort: Progression-free survival (PFS) assessed by a Blinded Independent Review Committee (BIRC) in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria (Lugano 2014 criteria) based on positron emission tomography and computed tomography (PET/CT based Lugano 2014 criteria) (Cheson et al 2014), R/R MZL cohort: PFS assessed by BIRC in accordance with CT based Lugano 2014 criteria
Detailed description
R/R FL cohort: Overall response rate (ORR) assessed by BIRC in accordance with PET/CT-based Lugano 2014 criteria., R/R FL cohort: Overall survival (OS), R/R MZL cohort: ORR determined by BIRC (CT based Lugano 2014 criteria), R/R FL cohort: PFS by investigator, ORR by Investigator, Duration of response (DOR), Complete response rate (CRR), time to response (TTR) and time to next anti-lymphoma treatment (TTNT) with PET/CT based Lugano 2014 criteria, R/R MZL cohort: OS, PFS by investigator, ORR by Investigator, DOR, CRR, TTR, TTNT with PET/CT based and CT based Lugano 2014 criteria, R/R FL and R/R MZL cohorts: Patient-reported outcomes (PROs) questionnaires: the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30], National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18], and European Quality of Life 5Dimension 5Level Questionnaire [EQ 5D 5L), R/R FL and R/R MZL cohorts: Incidence rate of adverse event, lab abnormalities, and vitals.
Interventions
DRUGLENALIDOMIDE
DRUGRITUXIMAB
DRUGOBINUTUZUMAB
DRUGZanubrutinib
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R/R FL cohort: Progression-free survival (PFS) assessed by a Blinded Independent Review Committee (BIRC) in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria (Lugano 2014 criteria) based on positron emission tomography and computed tomography (PET/CT based Lugano 2014 criteria) (Cheson et al 2014), R/R MZL cohort: PFS assessed by BIRC in accordance with CT based Lugano 2014 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| R/R FL cohort: Overall response rate (ORR) assessed by BIRC in accordance with PET/CT-based Lugano 2014 criteria., R/R FL cohort: Overall survival (OS), R/R MZL cohort: ORR determined by BIRC (CT based Lugano 2014 criteria), R/R FL cohort: PFS by investigator, ORR by Investigator, Duration of response (DOR), Complete response rate (CRR), time to response (TTR) and time to next anti-lymphoma treatment (TTNT) with PET/CT based Lugano 2014 criteria, R/R MZL cohort: OS, PFS by investigator, ORR by Investigator, DOR, CRR, TTR, TTNT with PET/CT based and CT based Lugano 2014 criteria, R/R FL and R/R MZL cohorts: Patient-reported outcomes (PROs) questionnaires: the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30], National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18], and European Quality of Life 5Dimension 5Level Questionnaire [EQ 5D 5L), R/R FL and R/R MZL cohorts: In | — |
Countries
Austria, Belgium, Bulgaria, Czechia, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed