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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07022223
Phase
PHASE2
Status
Recruiting
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Conditions

  • Marginal Zone Lymphoma(MZL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • orelabrutinib combined with rituximab regimen — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 11, 2025
Status verified
Mar 2025
Primary completion
Sep 11, 2027
Completion
Sep 11, 2029

Study Design

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

Arms

  • Experimental: 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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to 6 months ]

Central Contacts