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

Launched by SUN YAT-SEN UNIVERSITY · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two medications, Zanubrutinib and Rituximab, as a first-line treatment for patients with a specific type of lymphoma called mucosa-associated lymphoid tissue (MALT) lymphoma. The trial aims to see how effective and safe this treatment is for people who are newly diagnosed with advanced stages of MALT lymphoma or those whose condition has returned after previous local treatments. To participate, individuals must be at least 18 years old, have a confirmed diagnosis of MALT lymphoma, and meet certain health criteria, such as having no prior systemic treatment for lymphoma.

Participants in this study will be closely monitored by healthcare professionals to assess how well the treatment works and to watch for any side effects. They will need to attend regular appointments for tests and evaluations. It's important for potential participants to understand that they will need to sign a consent form and agree to follow the study procedures. This trial is currently recruiting, so it’s a good opportunity for eligible patients to access a new treatment option while contributing to medical research.

Gender

ALL

Eligibility criteria

• Key inclusion Criteria:
• • 1. Mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma confirmed by histopathology.
• • 2. Newly diagnosed with Ann Arbor stage III-IV or relapsed MALT after local treatment .
• • 3. No prior systemic anti-lymphoma therapy (except for H. pylori eradication therapy in H. pylori-positive gastric MALT patients).
• • 4. No histopathological transformation to high-grade lymphoma.
• • 5. At least one measurable lesion according to the Lugano 2014 criteria.
• • 7. 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.
• Key exclusion Criteria:
• • 1. Patients with a history of stroke, intracranial hemorrhage, or warfarin use within the past 6 months.
• • 2. Patients with central nervous system involvement.
• • 3. Patients who have undergone allogeneic hematopoietic stem cell transplantation in the past.
• • 4. Patients who have previously used BTK inhibitors or received CD20 monoclonal antibody therapy.
• • 5, 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.
• • 7. 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.
• • 9. 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.
• • 10. Pregnant or breastfeeding women and women of childbearing age unwilling to use contraception.
• • 11. Patients who have received anti-tumor therapy within 4 weeks prior to enrollment.
• • 12. 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.