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NCT Number: NCT07233720

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

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).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

Zhihua Yao, M.D. Ph.D

CONTACT

[email protected]

+8613592622292

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Zanubrutinib

Drug

160mg twice daily continuous oral administration.

Other names: Zanubrutinib pills

Rituximab

Drug

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

Other names: RiTUXimab Injection

Primary outcomes

  1. complete response rate

    Time frame: 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

    the total proportion of patients with complete response (CR)

Secondary outcomes

  1. objective response rate

    Time frame: 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

    the total proportion of patients with complete response (CR) and partial response (PR)

  2. progression-free survival

    Time frame: 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)

    the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

  3. overall survival

    Time frame: 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)

    from date of first day of treatment to the date of death by any cause

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

    Time frame: 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)

    the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihua Yao, M.D. Ph.D

CONTACT

[email protected]

+8613592622292

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

A Multicenter Prospective Real-world Study of Zanubrutinib Combined With Rituximab (ZR) in the First-line Treatment for Patients With Marginal Zone Lymphoma (MZL)

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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