Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage HP-negative Gastric MALT Lymphoma
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).
Timeline
- Start
- 2025-09-01
- Primary completion
- 2029-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | — |
| Background | Esomeprazole | Small molecule | 40 mg | — |
| Background | Metronidazole | Small molecule | 500 mg | Oral |
| Background | Tetracycline | Unknown | 500 mg | Oral |
| Background | bismuth tripotassium dicitrate | Unknown | 300 mg | Oral |