Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma

NCT ID: NCT07233720

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-18

Study Completion Date

2030-06-30

Brief Summary

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This is a prospective single arm, multi-center, real-world study to observe the efficacy and safety of ZR (Zanubrutinib combined with Rituximab) in the first-line treatment for patients with marginal zone lymphoma (MZL).

Detailed Description

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Conditions

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Marginal Zone Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Zanubrutinib Combined With Rituximab

Induction treatment:

Rituximab, 375mg/m2, Intravenous administration on day 1 (21 days/cycle); Zanubrutinib, 160mg twice daily continuous oral administration from 1 to 8 cycles (21 days/cycle)

Maintenance treatment:

Zanubrutinib, 160mg twice daily continuous oral administration for two years (28 days/cycle)

Zanubrutinib

Intervention Type DRUG

160mg twice daily continuous oral administration.

Rituximab

Intervention Type DRUG

375mg/m2, Intravenous administration on day 1 of each 3-week cycle

Interventions

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Zanubrutinib

160mg twice daily continuous oral administration.

Intervention Type DRUG

Rituximab

375mg/m2, Intravenous administration on day 1 of each 3-week cycle

Intervention Type DRUG

Other Intervention Names

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Zanubrutinib pills RiTUXimab Injection

Eligibility Criteria

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Inclusion Criteria

1. Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology
2. First-line treatment with the combination regimen of zanubrutinib and rituximab
3. No receiving systematic treatment before enrollment
4. Having at least one measurable lesions. Measurable lesions were defined as: the longest diameter of lymph node lesions in CT cross-sectional images \> 1.5 cm, or the longest diameter of the extranodal lesion is greater than 1.0cm
5. The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion Criteria

1. Other malignant tumor history or active malignant tumor need be treated
2. In addition to zanubrutinib and rituximab, other anti-tumor drug treatments were also received simultaneously (except for glucocorticoids aimed at controlling symptoms before formal treatment).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zhihua Yao, PhD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhihua Yao, M.D. Ph.D

Role: STUDY_DIRECTOR

Henan Cancer Hospital

Locations

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Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihua Yao, M.D. Ph.D

Role: CONTACT

+8613592622292

Facility Contacts

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Zhihua Yao, M.D. Ph.D

Role: primary

+8613592622292

Other Identifiers

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HNSZLYYNHL10

Identifier Type: -

Identifier Source: org_study_id

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