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Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage HP-negative Gastric MALT Lymphoma
Sponsor: National Taiwan University Hospital
Summary
We hypothesized that a proportion of patients with localized Helicobacter pylori-negative gastric MALT lymphoma may well respond to frontline Helicobacter pylori eradication therapy (HPE) and remain lymphoma-free for the long term. In addition, we hypothesized that for patients with antibiotics-unresponsive HP-negative gastric MALT lymphoma, the administration of a combination of clarithromycin and low-dose cyclophosphamide (CAMC) could result in tumor regression through the direct anti-neoplastic effects and the indirect immune modulatory effect. Therefore, in this proposal, we will design a prospective phase II study to evaluate the treatment efficacy of frontline HPE, consisting of two weeks of quadruple HPE regimen followed by four weeks of clarithromycin in patients with stage IE/IIE1 HP-negative gastric MALT lymphoma. In addition, we will treat patients who did not respond to HPE using combination regimens of clarithromycin and low-dose cyclophosphamide (CAMC).
Official title: Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage Helicobacter Pylori-negative Gastric Mucosa-associated Lymphoid Tissue Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-01
Completion Date
2030-12-31
Last Updated
2025-08-27
Healthy Volunteers
No
Conditions
Interventions
Esomeprazole, Bismuth tripotassium dicitrate, Tetracycline, and Metronidazole
1. Frontline antibiotics treatment (two weeks of quadruple HPE regimens followed by 4 weeks of clarithromycin). 2. If no response to frontline antibiotics treatment, second line immune-modulator regimens (CAMC, clarithromycin (CAM) and low-dose cyclophosphamide) will be prescribed
Locations (1)
National Taiwan University Hospital
Taipei, None Selected, Taiwan