MALT Lymphoma
Conditions
Keywords
MALT lymphoma, diffuse large B-cell lymphoma,, stomach, Helicobacter pylori, antibiotic therapy
Brief summary
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
Detailed description
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 MALToma. 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.
Interventions
Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus
Sponsors
National Health Research Institutes, Taiwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 MALToma. * 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 serology. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the efficacy of Helicobacter pylori eradication therapy with respect to objective regression rate and time to disease progression of primary low-grade gastric MALToma. | Four weeks after the completion of anti-H. pylori therapy by CT scan | Four weeks after the completion of anti-H. pylori therapy, patients shall have repeat endoscopy and abdominal CT to evaluate the H.pylori status and the response of MALToma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective regression rate and time to disease progression of primary low-grade gastric MALToma. | 3-6 months by EUS | atients who achieve complete or persistent partial response will receive no further treatment and have regular follow-up as section till tumor progression (relapse). |
Countries
Taiwan
Outcome results
None listed