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

Phase 2

Recruiting

• Conditions: The First Affiliated Hospital of Nanchang University
• Interventions: Drug: Orelabrutinib+R-CHOP

• Registration Number: NCT05933967
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15
• Primary Completion: 2024-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
orelabrutinib+R-CHOP	Orelabrutinib+R-CHOP	-

Primary Outcome Measures

Name	Time	Method
complete response rate	up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
ORR	up to 24 weeks	ORR is defined as the proportion of patients with a best response of CR or PR
The occurrence of adverse events and serious adverse events	up to 30 months	Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
2 years progression-free survival	From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]	2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
2 years overall survival	From date of receiving the first dose until the date of death from any cause,assessed up to 2 years	2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive

Trial Locations

Locations (2)

The First Ailliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences; 🇨🇳 Jinan, Shandong, China