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

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.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

DRUG

orelabrutinib 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Taizhou First People's Hospital

  collaborator OTHER

• Huzhou Central Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• Yuyao People's Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Shaoxing Central Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Ningbo People's Hospital

  collaborator UNKNOWN

• The People's Hospital of Quzhou

  collaborator OTHER

• Zhuji People's hospital

  collaborator UNKNOWN

• Affiliated Hangzhou First People's Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang 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

2025-05-05

Primary Completion

2026-10-31

Completion

2028-12-31

Countries

• China

Study Locations