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

Phase 2
Recruiting
Conditions
Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
Interventions
Registration Number
NCT06647732
Lead Sponsor
Sun Yat-sen University
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
42
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Zanubrutinib in combination with RituximabZanubrutinibEligible 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.
Zanubrutinib in combination with RituximabRituximabEligible 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 Measures
NameTimeMethod
Complete Response(CR)Up to 8 cycles (each cycle is 28 days)

Defined as the proportion of patients who achieve complete remission as the best response

Secondary Outcome Measures
NameTimeMethod
Time to Response(TTR)The time from the start of patient enrollment in the trial to the first efficacy assessment achieving CR or PR, assessed up tp 24 months

To investigate the preliminary anti-tumor efficacy

Objective response rate(ORR)Up to 8 cycles (each cycle is 28 days)

The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

Progression-free survival(PFS)From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

To investigate the preliminary anti-tumor efficacy

Event-free survival(EFS)The proportion of patients without disease progression, treatment discontinuation, or death for any reason since enrollment, assessed up to 24 months

To investigate the preliminary anti-tumor efficacy

Overall survival(OS)From the date of enrollment until the date of death from ant cause, assessed up to 24 months

To investigate the preliminary anti-tumor efficacy

Duration of Response(DOR)The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months

To investigate the preliminary anti-tumor efficacy

Trial Locations

Locations (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

🇨🇳

Guangzhou, Guangdong, China

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