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

NCT07233720 | Recruiting DMC

• 1 other identifier: HNSZLYYNHL10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Marginal Zone Lymphoma

Keywords

Marginal Zone Lymphoma; Zanubrutinib; Rituximab

Outcome Measures

Primary Outcomes (1)

• complete response rate

  the total proportion of patients with complete response (CR)

  every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment

Secondary Outcomes (4)

• objective response rate

  every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment

• progression-free survival

  from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)

• overall survival

  from date of the first cycle of treatment to the date of death from any cause (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)

• incidence and relationship with study drugs of grade 3-4 adverse events

  from the date of the first cycle of treatment to 24 months after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)

Study Arms (1)

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)

Drug: Zanubrutinib; Drug: Rituximab

Interventions

Zanubrutinib DRUG

160mg twice daily continuous oral administration.

Also known as: Zanubrutinib pills

Zanubrutinib Combined With Rituximab

Rituximab DRUG

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

Also known as: RiTUXimab Injection

Zanubrutinib Combined With Rituximab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology for first-line treatment.

You may qualify if:

• Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology
• First-line treatment with the combination regimen of zanubrutinib and rituximab
• No receiving systematic treatment before enrollment
• 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
• The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.

You may not qualify if:

• Other malignant tumor history or active malignant tumor need be treated
• 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).

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

zanubrutinib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhihua Yao, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhihua Yao, M.D. Ph.D

CONTACT

+8613592622292; zlyyyaozhihua1260@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: November 18, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

CN (1)