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

Shandong First Medical University

Status and phase: Enrolling; Phase 2

Conditions: The First Affiliated Hospital of Nanchang University

Treatments: Drug: Orelabrutinib+R-CHOP

Study type: Interventional

Funder types: Other

Identifiers

NCT05933967

SDCHI-NHL-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 31 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

orelabrutinib+R-CHOP

Experimental group

Treatment:

Drug: Orelabrutinib+R-CHOP