Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma

Summary

This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.

Conditions

• Marginal Zone Lymphoma(MZL)

Interventions

DRUG

orelabrutinib combined with rituximab regimen

All participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows: Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.

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

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  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

• Zhejiang University

  collaborator OTHER

• Zhuji 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

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-11

Primary Completion

2027-09-11

Completion

2029-09-11

Countries

• China

Study Locations