drugset / Trial / NCT05164770
Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
Non-Hodgkin lymphoma (NHL), with high aggressiveness and mortality, is one of the top ten high-incidence tumors in the world and is among the ten most prevalent cancers worldwide with the fastest growing incidence. Although novel immunotherapies represented by anti-CD20 monoclonal antibodies and CAR-T cell therapies have significantly improved the prognosis of B-NHL patients, there are still nearly one-third of patients who are resistant to initial treatment or relapse after remission. Zanubrutinib is an oral small molecule BTK inhibitor, and has shown good efficacy and safety in multiple subtypes of B-cell lymphoma. However, the efficacy of zanubrutinib in highly aggressive B-cell lymphoma remains to be further studied
Timeline
- Start
- 2021-03-01
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zanubrutinib | Small molecule | 160 mg | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Comparator | Doxorubicin liposome | Unknown | 30 mg/m2 | — |
| Comparator | Doxorubicin liposome | Unknown | 40 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 15 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 50 mg/m2 | — |
| Comparator | Methotrexate | Small molecule | 3.5 g | — |
| Comparator | Prednisone | Other / unclassified | 60 mg/m2 | — |
| Comparator | Prednisone | Other / unclassified | 100 mg | — |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | — |
| Comparator | Vindesine | Small molecule | 3 mg/m2 | — |