RecruitingPhase 2NCT07680933

Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

A Prospective, Phase II Clinical Study Protocol of Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

30 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Summary

This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT for people with dlbcl - diffuse large b cell lymphoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

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 standard immunochemotherapy with or without auto-HSCT

1+2.1 or 2.2 ±3 1\. Orelabrutinib: 150 mg once daily, orally, Days 1-28 2.1 Pola-R-CHP Regimen: Polatuzumab vedotin: 1.8 mg/kg, intravenous infusion, Day 1 Rituximab: 375 mg/m², intravenous infusion, Day 1 Cyclophosphamide: 750 mg/m², intravenous administration, Day 2 Doxorubicin: 50 mg/m², intravenous administration or per institutional guidelines, Day 2 Prednisone: 100 mg/day, orally, Days 2-6 2.2. R-CHOP Regimen: Rituximab: 375 mg/m², intravenous infusion, Day 0 Cyclophosphamide: 750 mg/m², intravenous administration, Day 1 Doxorubicin: 40-50 mg/m², intravenous administration or per institutional guidelines, Day 1 Vincristine: 1.4 mg/m², intravenous administration, Day 1 (maximum dose 2 mg) OR Vindesine: 4 mg, intravenous administration, Day 1 Prednisone: 100 mg/day, orally, Days 1-5 3\. auto-HSCT