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

NCT06134284 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-06-11

No results posted yet for this study

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.

Conditions

  • OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma

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.

Sponsors & Collaborators

  • Lixia Sheng

    lead OTHER

Principal Investigators

  • Chen · First Affiliated Hospital of Ningbo University

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
2023-01-02
Primary Completion
2026-12-31
Completion
2029-12-31

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 NCT06134284 on ClinicalTrials.gov