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Status unknownNCT02388581Updated Mar 25, 2016

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

A Phase 2 interventional study of Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole in Gastric Diffuse Large B-cell Lymphoma, sponsored by National Health Research Institutes, Taiwan. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by National Health Research Institutes, Taiwan · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Gastric Diffuse Large B-cell Lymphoma

Keywords

  • Helicobactor pylori, Hp
  • mucosa-associated lymphoid tissue-type lymphoma, MALToma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

National Health Research Institutes, Taiwan is the lead sponsor of 125 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients must have histologically confirmed H. pylori-positive primary gastric pure (de novo) gastric DLBCL.
  2. Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL.
  3. Patients must have evaluable disease by endoscopy and/or by computed tomography.
  4. Patients must have documented H. pylori infection before treatment, if any of the following test show positive result: histology, rapid urease test (CLO-test), C13 urease breath test, and serology.
  5. Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
  6. Patients who are either newly diagnosed or already starting anti-H. pylori therapy but not have follow-up endoscopy and biopsy are eligible.
  7. Patient must have signed the informed consent, and agree to provide achieved pathologic material for immunohistochemical / fluorescence in situ hybridization study and RT-PCR for t(11;18)(q21;q21) determination.

Exclusion criteria

Exclusion Criteria:

  1. Patients with extensive gastrointestinal tract involvement.
  2. Patients with previous history of extranodal lymphoma.
  3. Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node.
  4. Patients with cardiopulmonary status that do not allow repeat endoscopy.
  5. Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma.
  6. Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Anti-H. pylori Therapy

    Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole

    Drug: Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole

Interventions

  • DrugLansoprazole, Amoxicillin, Clarithromycin, Metronidazole

    Anti-H. pylori Therapy

    Also known as: Anti-H. pylori Therapy

06

What researchers measure

Primary outcomes

  1. The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL

    Time frame: 10 years

  2. The median time to pathologic complete remission (months) after completion of antibiotics for Hp-dependent gastric pure (de novo) DLBCL (patients have pCR after Hp eradication therapy [antibiotics])

    Time frame: 10 years

  3. The relapse-free survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy

    A nationwide study to prospectively validate

    Time frame: 10 years

Secondary outcomes

  1. The overall survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy

    Time frame: 10 years

  2. The Hp eradication rate (%)

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • National Health Research Institutes
    Zhunan, Miaoli County 35053, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02388581
Lead sponsor
National Health Research Institutes, Taiwan
Collaborators
National Taiwan University Hospital, Mackay Memorial Hospital, China Medical University Hospital, Taichung Veterans General Hospital, Changhua Christian Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Kaohsiung Medical University
Responsible party
Sponsor
First posted
Mar 17, 2015
Start date
Dec 2014
Primary completion
Dec 2017 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 25, 2016

Study contacts

Bor-Rong Chen, BS
Contact
brong@nhri.org.tw
886-2-26534401 ext. 25162
Sung-Hsin Kuo, MD, PhD.
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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