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

Primary Purpose

MALT Lymphoma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Omeprazole, Amoxicillin, Clarithromycin
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MALT Lymphoma focused on measuring MALT lymphoma, diffuse large B-cell lymphoma,, stomach, Helicobacter pylori, antibiotic therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 : 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. 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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omeprazole, Amoxicillin, Clarithromycin

Arm Description

Anti-H. pylori Therapy (Triple therapy)

Outcomes

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.
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.
atients who achieve complete or persistent partial response will receive no further treatment and have regular follow-up as section till tumor progression (relapse).

Full Information

First Posted
September 13, 2005
Last Updated
March 25, 2016
Sponsor
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00201422
Brief Title
Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MALT Lymphoma
Keywords
MALT lymphoma, diffuse large B-cell lymphoma,, stomach, Helicobacter pylori, antibiotic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omeprazole, Amoxicillin, Clarithromycin
Arm Type
Experimental
Arm Description
Anti-H. pylori Therapy (Triple therapy)
Intervention Type
Other
Intervention Name(s)
Omeprazole, Amoxicillin, Clarithromycin
Intervention Description
Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Four weeks after the completion of anti-H. pylori therapy by CT scan
Secondary Outcome Measure Information:
Title
objective regression rate and time to disease progression of primary low-grade gastric MALToma.
Description
atients who achieve complete or persistent partial response will receive no further treatment and have regular follow-up as section till tumor progression (relapse).
Time Frame
3-6 months by EUS

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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 : 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Tzong Chen, MD,PhD
Organizational Affiliation
Taiwan cooperative oncology group
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16174856
Citation
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.
Results Reference
result
Links:
URL
http://english.nhri.org.tw/inst_cancer/ca_TCOGresearch.php
Description
ISSN: 1460-2105,

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

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