Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage HP-negative Ga… (NCT07144657) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage HP-negative Gastric MALT Lymphoma
Taiwan40 participantsStarted 2025-09-01
Plain-language 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).
Who can participate
Age range
18 Years
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
. The patients must have histologically confirmed primary gastric MALT lymphoma by REAL/WHO classification
. The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALT lymphoma
. Patients must have evaluable disease by endoscopy and/or the nodal status by computed tomography 3.1 If patients have endoscopic lesions without computed tomography-demonstrating lesions are eligible.
.2 Endoscopic ultrasonography (EUS) is optional to evaluate the depth of tumor infiltration and for status of perigastric lymph node enlargement
. Patients must have documented to have no HP infection before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test, HP stool antigen, and serology; and all of the five tests have to be negative for the diagnosis of no evidence of HP infection.
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 treatment efficacies of frontline antibiotics treatment for Helicobacter pylori-negative gastric MALT lymphoma
. Patients must have either stage IE or IIE1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
. Patients must have signed the informed consent and agree to provide achieved pathologic material and tumor biopsy for translational study
. Patients must have signed the informed consent and agree to provide achieved blood samples for potential serum molecular studies and fecal samples for researches of gut microbiota
Exclusion criteria
. Active second malignancies during the last five years except non melanomatous skin cancer, carcinoma in situ of cervix, lobular or ductal carcinoma in situ of breast.
. Patients with previous history of extranodal lymphoma are not eligible.
. Patients with stage IIE2 or beyond disease: infiltration of regional lymph nodes not adjacent primary involved site.
. Patients with cardiopulmonary status that do not allow repeat examination are not eligible.
. Patients with prior chemo- or radiotherapy for their extragastric lymphoma are not eligible.