drugset
drugset / Trial / NCT07680933

Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

NCT07680933 ↗

Phase 2 Recruiting 30 enrolled The Affiliated Hospital of Xuzhou Medical University
NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.

Timeline

Start
2026-03-01
Primary completion
2027-06-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Orelabrutinib Small molecule 150 mg Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 40 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Polatuzumab Vedotin Other / unclassified 1.8 mg/kg Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous
Background Vindesine Small molecule 4 mg Intravenous

Indications

diffuse large B-cell lymphoma