NCT06228963

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma

Conditions

• MALT Lymphoma of Stomach
• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Triple 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)
DRUG	Triple therapy for eradication of Helicobacter Pylori	Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2024-01-29
• Last updated: 2024-02-23

Locations

1 site across 1 country: China