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:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201422
First received: September 13, 2005
Last updated: March 25, 2016
Last verified: March 2016
  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
MALT Lymphoma
Other: Omeprazole, Amoxicillin, Clarithromycin

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:
  • 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. [ Time Frame: Four weeks after the completion of anti-H. pylori therapy by CT scan ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • objective regression rate and time to disease progression of primary low-grade gastric MALToma. [ Time Frame: 3-6 months by EUS ] [ Designated as safety issue: No ]
    atients who achieve complete or persistent partial response will receive no further treatment and have regular follow-up as section till tumor progression (relapse).


Enrollment: 70
Study Start Date: June 1996
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omeprazole, Amoxicillin, Clarithromycin
Anti-H. pylori Therapy (Triple therapy)
Other: Omeprazole, Amoxicillin, Clarithromycin
Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus

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

Ages Eligible for Study:   Child, Adult, Senior
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
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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
Investigators
Principal Investigator: Li-Tzong Chen, MD,PhD Taiwan cooperative oncology group
  More Information

Publications:
Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00201422     History of Changes
Other Study ID Numbers: T1296 
Study First Received: September 13, 2005
Last Updated: March 25, 2016
Health Authority: Taiwan: Department of Health
Individual Participant Data  
Plan to Share IPD: No

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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 21, 2016