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

NCT07680933 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-02

No results posted yet for this study

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.

Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma

Interventions

DRUG

Orelabrutinib 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

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07680933 on ClinicalTrials.gov