RecruitingPhase 2

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

China42 participantsStarted 2024-10-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Complete Response(CR)

Timeframe: Up to 8 cycles (each cycle is 28 days)

Trial details

NCT IDNCT06647732

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-31

Contact for this trial

Qingqing Cai, MD. PhD.

02087342823 caiqq@sysucc.org.cn

View on ClinicalTrials.gov More Mucosa-associated Lymphoid Tissue Lymphoma (MALT) trials