NCT02388581

First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL

Multicentre, Prospective Study of First-line Antibiotic Therapy for Early-stage H. Pylori-Positive Gastric Pure (de Novo) Diffuse Large B-cell Lymphoma and Potential Predicting Factor for Treatment Outcome

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Aims: A nationwide study to prospectively validate 1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL 2. The durability of complete histological remission after antibiotics 3. The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL 4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in Taiwan. 5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics.

Detailed description

The study will validate the use of antibiotics as first-line therapy for stage IE (and perhaps IIE-1) Hp-positive gastric pure (de novo) DLBCL. The status of NF-kB, BCL10, BAFF, and CagA IHC nuclear staining will help to tailoring the treatment for early-stage gastric pure (de novo) DLBCL. And 50-60% of stage IE / IIE-1 pure (de novo) DLBCL patients can be cured by 2-weeks of antibiotics rather than the 6-months of relatively toxic front-line systemic chemotherapy. The investigators shall also elucidate the distribution of CYP2C18/19 in patients with pure (de novo) DLBCL and their association with the efficacy of sequential antibiotics for eradication of Hp infection.

Conditions

• Gastric Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole	Anti-H. pylori Therapy

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2024-12-01
• First posted: 2015-03-17
• Last updated: 2016-03-25

Locations

1 site across 1 country: Taiwan