Overview

This trial is active, not recruiting.

Condition gastric low-grade malt lymphoma with helicobacter pylori positive
Treatment rabeprazole sodium
Sponsor Eisai Co., Ltd.
Start date January 2011
End date February 2017
Trial size 100 participants
Trial identifier NCT01264822, PRT10T

Summary

To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
rabeprazole 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.

Primary Outcomes

Measure
Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori
time frame: Every 3 months within the 1st year and every 6 months
Transition rate to secondary therapy for eradication of Helicobacter pylori
time frame: Every 6 months within the 1st year and every 12 months as needed

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..