Zanubrutinib and Rituximab for treating MALT lymphoma
Zanubrutinib Plus Rituximab as Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT): a Single-arm, Open-label, Multicenter, Phase II Study（ZAMA）
This study is testing if combining the drugs Zanubrutinib and Rituximab can help people with MALT lymphoma get better as a first treatment option.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Zanubrutinib, Rituximab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06647732 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Zanubrutinib combined with Rituximab as a first-line treatment for patients diagnosed with mucosa-associated lymphoid tissue (MALT) lymphoma. It is a prospective, single-arm, multicenter phase II trial that aims to determine the complete remission rate of this combination therapy. Patients will receive a specified dosage of Rituximab and Zanubrutinib over a series of treatment cycles, followed by observation for those who achieve remission. The study focuses on newly diagnosed patients or those who have relapsed after local treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or relapsed MALT lymphoma who meet specific health criteria.
Not a fit: Patients with a history of high-grade lymphoma transformation or those who have received prior systemic anti-lymphoma therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with MALT lymphoma, potentially improving remission rates.
How similar studies have performed: While there have been studies on similar therapies, this specific combination of Zanubrutinib and Rituximab for MALT lymphoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai, MD. PhD.
- Email: caiqq@sysucc.org.cn
- Phone: 02087342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.