First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL (NCT02388581) | Clinical Trial Compass
UnknownPhase 2
First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL
Taiwan30 participantsStarted 2014-12
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have histologically confirmed H. pylori-positive primary gastric pure (de novo) gastric DLBCL.
. Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL.
. Patients must have evaluable disease by endoscopy and/or by computed tomography.
. 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.
. 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.
. Patients who are either newly diagnosed or already starting anti-H. pylori therapy but not have follow-up endoscopy and biopsy are eligible.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
Timeframe: 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])
Timeframe: 10 years
3
The relapse-free survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
Timeframe: 10 years
Trial details
NCT IDNCT02388581
SponsorNational Health Research Institutes, Taiwan
. Patients with extensive gastrointestinal tract involvement.
. Patients with previous history of extranodal lymphoma.
. Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node.
. Patients with cardiopulmonary status that do not allow repeat endoscopy.
. Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma.
. Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study.