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

Sponsor
Lixia Sheng
Study ID
NCT06134284
Phase
PHASE4
Status
Recruiting
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Conditions

  • OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib combined with rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 2, 2023
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OR regimen
    The specific medication regimen for the OR regimen is as follows: Orelabrutinib 150mg orally once daily; Rituximab 375mg/m² intravenous infusion, administered every 21 days.

Primary Outcome Measure

Objective Response Rate [ Time Frame: up to 8 months ]

Central Contacts