Clinical trial · Interventional
Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage HP-negative Gastric MALT Lymphoma
Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage Helicobacter Pylori-negative Gastric Mucosa-associated Lymphoid Tissue Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MALT Lymphoma of Stomach | Gastric Mucosa-Associated Lymphoid Tissue Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esomeprazole, Bismuth tripotassium dicitrate, Tetracycline, and Metronidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The treatment efficacy of antibiotics treatment
- description
- 1. Frontline antibiotics treatment (two weeks of quadruple HPE regimens followed by 4 weeks of clarithromycin). 2. Second line immune-modulator regimens (CAMC, clarithromycin (CAM) and low-dose cyclophosphamide) for antibiotics-unresponsive HP-negative gastric MALT lymphoma.
- interventionNames
- Drug: Esomeprazole, Bismuth tripotassium dicitrate, Tetracycline, and Metronidazole
Primary outcomes (1)
- measure
- The treatment efficacies of frontline antibiotics treatment for Helicobacter pylori-negative gastric MALT lymphoma
- timeFrame
- 2 years
- description
- 1\. The overall response rate (including complete remission \[CR\] and partial remission \[PR\]) for frontline antibiotics treatment (two weeks of quadruple HPE regimens followed by 4 weeks of clarithromycin) in stage IE/IIE1 HP-negative gastric MALT lymphoma. 2 The median time to CR or PR after completion of antibiotics and duration of CR or PR. 3 The overall response rate (including CR and PR) for immune treatment (CAMC) in antibiotics-unresponsive HP-negative gastric MALT lymphoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patients must have histologically confirmed primary gastric MALT lymphoma by REAL/WHO classification 2. The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALT lymphoma 3. 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. 3.2 Endoscopic ultrasonography (EUS) is optional to evaluate the depth of tumor infiltration and for status of perigastric lymph node enlargement 4. 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. 5. 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. 6. Patients must have signed the informed consent and agree to provide achieved pathologic material and tumor biopsy for translational study 7. 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: 1. 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. 2. Patients with previous history of extranodal lymphoma are not eligible. 3. Patients with stage IIE2 or beyond disease: infiltration of regional lymph nodes not adjacent primary involved site. 4. Patients with cardiopulmonary status that do not allow repeat examination are not eligible. 5. Patients with prior chemo- or radiotherapy for their extragastric lymphoma are not eligible.
References
Publications (0)
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