MALT LymphomaNCT00201422
Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma
A study testing Omeprazole, Amoxicillin, Clarithromycin in people with MALT Lymphoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MALT Lymphoma
- What is being tested?
- Omeprazole, Amoxicillin, Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 1996to Jan 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 .
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- MALT Lymphoma
- Being tested
- Omeprazole, Amoxicillin, Clarithromycin
- Keywords
- MALT lymphoma, diffuse large B-cell lymphoma,, stomach, Helicobacter pylori, antibiotic therapy
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole, Amoxicillin, ClarithromycinOther
Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole, Amoxicillin, Clarithromycin | Experimental | Anti-H. pylori Therapy (Triple therapy) Receives: Other: Omeprazole, Amoxicillin, Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
atients who achieve complete or persistent partial response will receive no further treatment and have regular follow-up as section till tumor progression (relapse).
Measured: 3-6 months by EUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 1996
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MALT LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, MD,PhD, Principal investigator, Taiwan cooperative oncology group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201422
- Sponsor's protocol ID
- T1296
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16174856
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00201422
- Acronym / sponsor ID
- T1296
- Conditions
- MALT Lymphoma
- Keywords
- MALT lymphoma, diffuse large B-cell lymphoma,, stomach, Helicobacter pylori, antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Jun 1996
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omeprazole, Amoxicillin, Clarithromycin | Experimental | Other: Omeprazole, Amoxicillin, ClarithromycinAnti-H. pylori Therapy (Triple therapy) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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 :
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole, Amoxicillin, ClarithromycinOmeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus | Other | Omeprazole, Amoxicillin, Clarithromycin |
Primary outcome
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
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.
1 secondary outcome
objective regression rate and time to disease progression of primary low-grade gastric MALToma.
Time frame: 3-6 months by EUS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Results publication: PubMed 16174856Chen 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.
- ISSN: 1460-2105,Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, MD,PhD principal investigator
Taiwan cooperative oncology group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeprazole, Amoxicillin, Clarithromycin in people with MALT Lymphoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.