drugset / Trial / NCT05097443

Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma

NCT05097443

Phase 3 Unknown 130 enrolled Shandong Provincial Hospital
NaSingle-groupOpen-labelTreatment

Summary

B-cell non-Hodgkin's lymphoma (B-NHL) is the most common type of NHL. 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. R-CHOP combined with novel drugs was expected to improve the prognosis. Therefore, this study aimed to investigate the potential of Orelabrutinib combined with Rituximab and chemotherapy.

Timeline

Start
2021-04-15
Primary completion
2023-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2
Subject Doxorubicin Other / unclassified 30 mg/m2
Subject Doxorubicin Other / unclassified 40 mg/m2
Subject Doxorubicin Other / unclassified 50 mg/m2
Subject Epirubicin Small molecule 15 mg/m2
Subject Etoposide Small molecule 50 mg/m2
Subject Methotrexate Small molecule 3.5 g
Subject Orelabrutinib Small molecule 150 mg
Subject Prednisone Other / unclassified 60 mg/m2
Subject Prednisone Other / unclassified 100 mg
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject Vincristine Small molecule 1.4 mg/m2
Subject Vindesine Small molecule 3 mg/m2