Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06134284
PHASE4

Clinical Study of OR for Second-line Treatment of Refractory MZL

Sponsor: Lixia Sheng

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.

Official title: Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2023-01-02

Completion Date

2029-12-31

Last Updated

2024-06-11

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib combined with rituximab

This is a single-arm trial. Patients with relapsed/refractory marginal zone lymphoma will be treated with the OR regimen. The treatment plan is as follows: Orelabrutinib 150mg oral administration once a day, Day 1-21; Rituximab 375mg/m² intravenous infusion, Day 1. Each cycle is 21 days. PET-CT evaluation will be conducted after 4 cycles. If a partial response (PR) or better is achieved, the patient will receive further treatment with the OR regimen for an additional 4 cycles before transitioning to single-agent maintenance therapy with either rituximab or obinutuzumab. If a PR or better is not achieved after 4 cycles, the patient will discontinue from the trial.

Locations (3)

The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital

Hangzhou, Zhejiang, China

86-574-87085596

Ningbo, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China