Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive Clinical Trial

Official title:

Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264822
• Other study ID #: PRT10T
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: February 23, 2017
• Start date: January 13, 2011
• Est. completion date: November 17, 2016

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 17, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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