RecruitingPhase 2NCT07078500

Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

A Prospective, Single-Arm, Multicenter Clinical Study of Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

48 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive Non-GCB diffuse large B-cell lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding orelabrutinib (a targeted therapy) to a standard chemotherapy regimen (called Pola-R-CHP) helps improve outcomes for patients with newly diagnosed non-GCB diffuse large B-cell lymphoma — a specific subtype of aggressive blood cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with diffuse large B-cell lymphoma (DLBCL), non-GCB subtype, confirmed by biopsy - You have not yet received any treatment for this cancer - You have at least one measurable tumor - Your overall health is adequate (ECOG 0–2) - Your life expectancy is at least 6 months **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - Your DLBCL was transformed from another type of lymphoma - You have primary mediastinal large B-cell lymphoma or Burkitt lymphoma - Your blood counts (white blood cells, platelets) are too low at screening - Your liver enzymes (ALT or AST) are significantly elevated 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 combined with the Pola-R-CHP regimen

Enrolled patients will receive six cycles of orelabrutinib in combination with the Pola-R-CHP regimen, with each 21-day period being one cycle. At the end of the six cycles, an interim efficacy evaluation will be conducted. Patients with a response of CR or PR will receive an additional two cycles of orelabrutinib in combination with rituximab and undergo a final efficacy evaluation. Patients with a response of CR/PR after eight cycles of induction therapy will receive maintenance treatment with orelabrutinib for up to two years.


Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT07078500


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