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

NCT05933967 · tracked via the Priya Life Science China tracker

Sponsor

Shandong Cancer Hospital and Institute

Phase

Phase 2

Started

2023-06-01

Last updated

2023-08-15

Condition(s) studied

The First Affiliated Hospital of Nanchang University

Investigational drug(s) / intervention(s)

Orelabrutinib+R-CHOP

Orelabrutinib+R-CHOP: Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

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

Primary outcome measure(s)

complete response rate — up to 24 weeks

Trial sites (2)

Facility	City	Region	Status
The First Ailliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05933967 on ClinicalTrials.gov ↗ ← All trials in China