NCT06647732

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

Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT): a Single-arm, Open-label, Multicenter, Phase II Study（ZAMA）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The purpose of this study is 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. Treatrment: 1. Rituximab: 375 mg/m², administered once a week in 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. Patients with partial remission (PR) or stable disease (SD) will receive 2 additional cycles. The primary study endpoint is the complete remission rate of Zanubrutinib in combination with Rituximab in the treatment of newly diagnosed mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma.

Conditions

• Mucosa-associated Lymphoid Tissue Lymphoma (MALT)

Interventions

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

Timeline

• Start date: 2024-10-30
• Primary completion: 2028-08-31
• Completion: 2028-09-30
• First posted: 2024-10-18
• Last updated: 2026-01-15

Locations

1 site across 1 country: China