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

A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

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.

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

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