Relapsed/Refractory Follicular Lymphoma
Conditions
Interventions
-Experimental: Arm A: Zanubrutinib plus Obinutuzumab
Drug: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsul
Sponsors
Tsumura Akari
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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 -Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (< 24 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Poland, Portugal, Puerto Rico, Republic of Korea, Romania, South Africa, Spain, Switzerland, Turkey, United Kingdom, US
Contacts
Public ContactReceipt Center IQVIA jRCT Inquiry
IQVIA Services Japan G.K.
Outcome results
None listed