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

This study has been completed.
Sponsor:
Collaborators:
National Taiwan University Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201422
First received: September 13, 2005
Last updated: April 2, 2009
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
MALT Lymphoma
Drug: Omeprazole,Amoxicillin,Clarithromycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • therapeutic effectiveness

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

Estimated Enrollment: 70
Study Start Date: June 1996
Estimated Study Completion Date: January 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201422

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Li-Tzong Chen, MD,PhD Taiwan cooperative oncology group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201422     History of Changes
Other Study ID Numbers: T1296
Study First Received: September 13, 2005
Last Updated: April 2, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
MALT lymphoma
diffuse large B-cell lymphoma,
stomach
Helicobacter pylori
antibiotic therapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Amoxicillin
Clarithromycin
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 20, 2014