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

NCT06647732 | Recruiting Phase 2

• 1 other identifier: B2024-594-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucosa-associated Lymphoid Tissue Lymphoma (MALT)

Outcome Measures

Primary Outcomes (1)

• Complete Response(CR)

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

  Up to 8 cycles (each cycle is 28 days)

Secondary Outcomes (6)

• Objective response rate(ORR)

  Up to 8 cycles (each cycle is 28 days)

• 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

• 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

• Overall survival(OS)

  From the date of enrollment until the date of death from ant cause, assessed up to 24 months

• 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

Study Arms (1)

Zanubrutinib in combination with Rituximab

EXPERIMENTAL

Eligible 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.

Drug: Zanubrutinib; Drug: Rituximab

Interventions

Zanubrutinib DRUG

160 mg, administered twice daily from Day 1 to Day 28 (D1-D28)

Zanubrutinib in combination with Rituximab

Rituximab DRUG

375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6 (C2-C6)

Zanubrutinib in combination with Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma confirmed by histopathology.
• Newly diagnosed with Ann Arbor stage III-IV or relapsed MALT after local treatment .
• No prior systemic anti-lymphoma therapy (except for H. pylori eradication therapy in H. pylori-positive gastric MALT patients).
• No histopathological transformation to high-grade lymphoma.
• At least one measurable lesion according to the Lugano 2014 criteria.
• \. Age ≥ 18 years, with no gender restrictions. 7. An ECOG performance status score of 0-2. 8. An expected survival time of more than 12 months. 9. Adequate bone marrow, cardiac, pulmonary, liver, and kidney function. 10. Willing to participate in the clinical study; fully informed and aware of the study, having signed the informed consent form; willing and able to comply with all study procedures.

You may not qualify if:

• Patients with a history of stroke, intracranial hemorrhage, or warfarin use within the past 6 months.
• Patients with central nervous system involvement.
• Patients who have undergone allogeneic hematopoietic stem cell transplantation in the past.
• Patients who have previously used BTK inhibitors or received CD20 monoclonal antibody therapy.
• , Patients with active infections, except for tumor-related B-symptom fever. 6. Patients with a concurrent history of other malignancies, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
• \. Patients receiving potent cytochrome P450 inhibitors. 8. Patients with severe cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or a history of myocardial infarction within the past 12 months.
• \. Patients, as judged by the investigator, who have significant organ dysfunction or uncontrollable comorbidities that pose a safety risk, or who have absorption and metabolism issues with Zanubrutinib.
• \. Pregnant or breastfeeding women and women of childbearing age unwilling to use contraception.
• \. Patients who have received anti-tumor therapy within 4 weeks prior to enrollment.
• \. Patients with active chronic hepatitis B or active hepatitis C. 13. Patients who have received systemic corticosteroid treatment or other immunosuppressive therapy within 14 days prior to the start of study treatment.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Gansu Cancer Hospital: collaborator
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator
• Beijing Tongren Hospital: collaborator
• Tongji Medical College of Huazhong University of Science & Technology: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Shenzhen People's Hospital: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 51000, 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

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

02087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-10

Locations

CN (1)