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

MALT Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201422
• Other study ID #: T1296
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 25, 2016
• Start date: June 1996
• Est. completion date: January 2004

Study information

• Verified date: March 2016
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• MALT Lymphoma

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	3-6 months by EUS	No