Trial intelligence / Profile preview

Orelabrutinib + R-CDOP in High-Risk DLBCL

NCT06290817Phase 2

Key facts

Status
Recruiting
Start
Mar 2023
Primary completion
Mar 2025
Countries
1
Sponsor
Second Affiliated Hospital of Zhejiang University School of Medicine
Modality
Small Molecules
Conditions
diffuse large B-cell lymphoma (DLBCL)
01

Overview

Phase 2, open-label, single-arm trial of orelabrutinib in diffuse large B-cell lymphoma (DLBCL), sponsored by Second Affiliated Hospital of Zhejiang University School of Medicine. Primary endpoint: 2-year central nervous system relapse rate. Started Mar 2023; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Orelabrutinib + R-CDOP

    Orelabrutinib 150mg QD + Rituximab, Cyclophosphamide, Liposomal Doxorubicin, Vincristine, Prednisone

03

Endpoints

Primary

  • 2-year central nervous system relapse rate

Secondary

  • Complete Response Rate

  • Overall Response Rate

  • Overall Survival

  • Progression-Free Survival

  • Occurrence of hematologic and non-hematologic adverse events

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