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A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

Recruiting
18-70 years
All
Phase 2

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Overview

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.

Description

The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen(21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy

Eligibility

Inclusion Criteria:

  • Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
    • Age 18-70 years
    • ECOG performance status 0-2
    • Ann Arbor stage II-IV
    • 8.Subjects who in line with the testing standard of the clinical trial laboratory
    • Life expectancy ≥ 3months

Exclusion Criteria:

  • • systemic lymphoma involved CNS.
    • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
    • uncontrolled infections (including HBV, HCV, HIV/AIDS)
    • Subjects who prepared for transplantation
    • Pregnancy or active lactation

Study details
    The First Affiliated Hospital of Nanchang University

NCT05933967

Shandong Cancer Hospital and Institute

27 January 2024

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