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
SexALL
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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.
Exclusion criteria
✕. Patients with extensive gastrointestinal tract involvement.
✕
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 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.