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

Shandong Cancer Hospital and Institute2 sites in 1 country31 target enrollmentJune 1, 2023

ConditionsThe First Affiliated Hospital of Nanchang University

InterventionsOrelabrutinib+R-CHOP

DrugsOrelabrutinib+R-CHOP

Overview

Phase: Phase 2
Intervention: Orelabrutinib+R-CHOP
Conditions: The First Affiliated Hospital of Nanchang University
Sponsor: Shandong Cancer Hospital and Institute
Enrollment: 31
Locations: 2
Primary Endpoint: complete response rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 1, 2023

End Date

December 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong Cancer Hospital and Institute

Responsible Party

Principal Investigator

Zengjun Li

Head of the Hematology Department

Shandong Cancer Hospital and Institute

Eligibility Criteria

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

Arms & Interventions

orelabrutinib+R-CHOP

Intervention: Orelabrutinib+R-CHOP

Outcomes

Primary Outcomes

complete response rate

Time Frame: up to 24 weeks

Secondary Outcomes

ORR(up to 24 weeks)
The occurrence of adverse events and serious adverse events(up to 30 months)
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 overall survival(From date of receiving the first dose until the date of death from any cause,assessed up to 2 years)