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Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-Grade B Cell Lymphoma of Mucosa-Associated Lymphoid Tissue Type of The Stomach

Phase 2
Not Enrolling
MALT Lymphoma

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Trial Information

Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-Grade B Cell Lymphoma of Mucosa-Associated Lymphoid Tissue Type of The Stomach

To investigate the prevalence of H. pylori infection in patients with early stage of primary
low-grade B cell lymphoma of MALT of the stomach in Taiwan.

-To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1
primary low-grade B cell lymphoma of MALT of the stomach.

To evaluate the efficacy of Helicobacter pylori eradication therapy with respect to
objective regression rate and time to disease progression of primary low-grade gastric

To estimate any differences in therapeutic efficacy related to different stage of
disease,eg. stage IE v.s. stage IIE-1.

To identify the causes of treatment failure, such as the stage of tumor, the presence of
large cell component, and/or persistent, reactivation or reinfection of H. pylori etc.

Inclusion Criteria:

- The patients must have histologically confirmed primary low-grade B-cell lymphoma of
MALT of the stomach which including the following types : diffuse small lymphocytic,
diffuse small cleaved, and some diffuse mixed small and large cell types by Working
Formulation (Harris NL et al. 1994)(20).

- The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson :

1. No enlargement of peripheral or mediastinal lymph node;

2. Peripheral blood smear revealing no leukemic or lymphomatous abnormalities;

3. Predominant of alimentary tract lesions with any adenopathy corresponding to
accepted lymphatic drainage route; and

4. No involvement of liver or spleen except by extension of contiguous disease .

- The monoclonality of B-cell must be confirmed by either immunohisto- chemistry
(light-chain restriction) or molecular technique (IgH rearrangement).

- The patient must have no prior chemotherapy or radiotherapy for his/her gastric

- Patients must have evaluable disease by endoscopy and the nodal status by computed
tomography. Endoscopic ultrasonography (EUS)* is optional and for reference only.

- H. pylori infection will be evaluated by the following tests: histology, rapid urease
test (CLO-test), and serology C13-urea breath test (UBT) and bacterial culture* are
optional and for reference only.

- The following will be considered to have H. pylori infection : at least two of the
following 3 tests show positive results, rapid urease test (CLO-test), histology and

- For C13-urea breath test, rapid urease test and histology to examine H. pylori,
the examination must be performed at least 4 weeks apart from the latest
antibiotics or non-steroid anti-inflammatory drug ingestion.

- Patients must have either stage IE or IIE-1 disease, according to an adaptation of
the Ann Abor staging system modified by Musshoff for primary extranodal lymphoma.

- Stage IE : lymphoma confined to the gastric wall without lymph node involvement.

- Stage IIE : localized involvement of one or more GI site(s) on one side of the
diaphragm with lymph node infiltration, any depth of lymphoma infiltration into the
gut wall.

- Stage IIE-1 : infiltration of adjacent lymph node.

- Patient must have signed the informed consent.

Exclusion Criteria:

- Patients who have extensive gastrointestinal tract involvement are not eligible.

- Patients who have had previous history of extranodal lymphoma are not eligible.

- Patients who have disease beyond stage IIE-2: infiltration of regional lymph node,
e.g. paraaortic, renal hilar, retroperitoneal, mesenteric, or lymph node of
gastrosplenic ligment and of hepatoduodenal ligment are not eligible.

- Patients who had a history of allergic reaction to Amoxicillin and Erythromycin
/Clarithromycin are not eligible.

- Patients whose cardiopulmonary status not allow him/her to have repeat endoscopy are
not eligible.

- Patients who had prior surgery, chemo- or radiotherapy for their primary gastric
lymphoma are not eligible.

- Patients who had previous anti-H. pylori therapy are not eligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

therapeutic effectiveness

Principal Investigator

Li-Tzong Chen, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taiwan cooperative oncology group


Taiwan: Department of Health

Study ID:




Start Date:

June 1996

Completion Date:

January 2004

Related Keywords:

  • MALT Lymphoma
  • MALT lymphoma
  • diffuse large B-cell lymphoma,
  • stomach
  • Helicobacter pylori
  • antibiotic therapy
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone