Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive
Conditions
Keywords
Rabeprazole Sodium, Helicobacter pylori, stomach neoplasms
Brief summary
To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori
Interventions
DRUGRabeprazole Sodium
The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg. The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily. If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg.
Sponsors
Eisai Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive * The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5
Exclusion criteria
* With diffuse large B-cell lymphoma * Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma * Corresponding to contraindication of each drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori | Every 3 months within the 1st year and every 6 months |
| Transition rate to secondary therapy for eradication of Helicobacter pylori | Every 6 months within the 1st year and every 12 months as needed |
Countries
Japan
Outcome results
None listed