Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT)

Sponsor
Sun Yat-sen University
Study ID
NCT06647732
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mucosa-associated Lymphoid Tissue Lymphoma (MALT)

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    160 mg, administered twice daily from Day 1 to Day 28 (D1-D28)
  • Rituximab — DRUG
    375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6)

Study Details

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Zanubrutinib in combination with Rituximab as a first-line treatment for patients with mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma.

Key Dates

Start date
Oct 30, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2028
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: Zanubrutinib in combination with Rituximab
    Eligible patients will receive: 1. Rituximab: 375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6). 2. Zanubrutinib: 160 mg, administered twice daily from Day 1 to Day 28 (D1-D28). Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) will end treatment and enter observation follow-up, while patients with partial remission (PR) or stable disease (SD) will receive an additional 2 cycles.

Primary Outcome Measure

Complete Response(CR) [ Time Frame: Up to 8 cycles (each cycle is 28 days) ]

Central Contacts