RecruitingPhase 2NCT06228963

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial

Sponsor

Fudan University

Enrollment

160 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

MALT Lymphoma of Stomach Helicobacter Pylori Infection

Summary

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called orelabrutinib for patients with a rare type of stomach lymphoma called gastric MALT lymphoma that is associated with a bacterial infection called Helicobacter pylori (H. pylori). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of gastric MALT lymphoma - You currently have an active H. pylori infection - Your lymphoma is at an early stage (Lugano staging I or II1) - You are in good physical condition (ECOG 0-2) - You have measurable disease **You may NOT be eligible if...** - Your lymphoma has spread beyond the stomach and nearby lymph nodes - You do not have an active or confirmed H. pylori infection - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You are currently taking certain medications that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTriple therapy for eradication of Helicobacter Pylori and Orelabrutinib

Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) plus Orelabrutinib for 8 weeks (or until progression, intolerable toxicity, death, or withdrawal from the study)

DRUGTriple therapy for eradication of Helicobacter Pylori

Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06228963

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