RecruitingPhase 2NCT05933967

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


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

31 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called orelabrutinib (a targeted therapy that blocks a cancer-promoting protein) to a standard chemotherapy regimen (R-CHOP) improves outcomes for people newly diagnosed with double expression diffuse large B-cell lymphoma (DE-DLBCL), an aggressive type of blood cancer. **You may be eligible if...** - You are aged 18–70 - You have been newly diagnosed with double expression DLBCL - Your cancer is at stage II–IV (spread beyond one lymph node area) - You are in reasonable health (ECOG 0–2) - You have a life expectancy of at least 3 months - Your lab results (blood counts, organ function) meet required standards **You may NOT be eligible if...** - The lymphoma has spread to the brain or spinal fluid - You have uncontrolled heart, blood clotting, or autoimmune diseases - You have uncontrolled infections (including hepatitis B or C, or HIV) - You are being considered for a transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib+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.


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

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NCT05933967