Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma

NCT00201422 | Completed DMC

• 1 other identifier: T1296
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

MALT Lymphoma

Keywords

MALT lymphoma; diffuse large B-cell lymphoma,; stomach; Helicobacter pylori; antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• 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, patients shall have repeat endoscopy and abdominal CT to evaluate the H.pylori status and the response of MALToma.

  Four weeks after the completion of anti-H. pylori therapy by CT scan

Secondary Outcomes (1)

• objective regression rate and time to disease progression of primary low-grade gastric MALToma.

  3-6 months by EUS

Study Arms (1)

Omeprazole, Amoxicillin, Clarithromycin

EXPERIMENTAL

Anti-H. pylori Therapy (Triple therapy)

Other: Omeprazole, Amoxicillin, Clarithromycin

Interventions

Omeprazole, Amoxicillin, Clarithromycin OTHER

Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus

Omeprazole, Amoxicillin, Clarithromycin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :
• No enlargement of peripheral or mediastinal lymph node;
• Peripheral blood smear revealing no leukemic or lymphomatous abnormalities;
• Predominant of alimentary tract lesions with any adenopathy corresponding to accepted lymphatic drainage route; and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

• Chen LT, Lin JT, Tai JJ, Chen GH, Yeh HZ, Yang SS, Wang HP, Kuo SH, Sheu BS, Jan CM, Wang WM, Wang TE, Wu CW, Chen CL, Su IJ, Whang-Peng J, Cheng AL. Long-term results of anti-Helicobacter pylori therapy in early-stage gastric high-grade transformed MALT lymphoma. J Natl Cancer Inst. 2005 Sep 21;97(18):1345-53. doi: 10.1093/jnci/dji277.

  PMID: 16174856 RESULT

Related Links

• ISSN: 1460-2105,

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse

Interventions

Omeprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Li-Tzong Chen, MD,PhD

  Taiwan cooperative oncology group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 1996
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: March 28, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)