drugset / Trial / NCT05100862
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-03-10
- Primary completion
- 2028-07
- Completion
- 2030-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Comparator | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Zanubrutinib | Small molecule | 160 mg | Oral |
| Subject | Zanubrutinib | Small molecule | 320 mg | Oral |