Gastric Diffuse Large B-cell LymphomaPhase 2NCT02388581
First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL
A Phase 2 study testing Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole in people with Gastric Diffuse Large B-cell Lymphoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
Aims: A nationwide study to prospectively validate 1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL 2. The durability of complete histological remission after antibiotics 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Diffuse Large B-cell Lymphoma
- What is being tested?
- Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2014to Dec 2024
- Phase
- Phase 2
- 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
- Patients must have histologically confirmed H. pylori-positive primary gastric pure (de novo) gastric DLBCL.
- Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL.
- Patients must have evaluable disease by endoscopy and/or by computed tomography.
- Patients must have documented H. pylori infection before treatment, if any of the following test show positive result: histology, rapid urease test (CLO-test), C13 urease breath test, and serology.
- Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
- Patients who are either newly diagnosed or already starting anti-H. pylori therapy but not have follow-up endoscopy and biopsy are eligible.
- Patient must have signed the informed consent, and agree to provide achieved pathologic material for immunohistochemical / fluorescence in situ hybridization study and RT-PCR for t(11;18)(q21;q21) determination.
Who cannot join
- Patients with extensive gastrointestinal tract involvement.
- Patients with previous history of extranodal lymphoma.
- Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node.
- Patients with cardiopulmonary status that do not allow repeat endoscopy.
- Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma.
- Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Health Research Institutes
Zhunan, Miaoli County, 35053
About this study
Official title: Multicentre, Prospective Study of First-line Antibiotic Therapy for Early-stage H. Pylori-Positive Gastric Pure (de Novo) Diffuse Large B-cell Lymphoma and Potential Predicting Factor for Treatment Outcome
Aims: A nationwide study to prospectively validate
- The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
- The durability of complete histological remission after antibiotics
- The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL
- The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in Taiwan.
- The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics.
Read the detailed description
The study will validate the use of antibiotics as first-line therapy for stage IE (and perhaps IIE-1) Hp-positive gastric pure (de novo) DLBCL. The status of NF-kB, BCL10, BAFF, and CagA IHC nuclear staining will help to tailoring the treatment for early-stage gastric pure (de novo) DLBCL. And 50-60% of stage IE / IIE-1 pure (de novo) DLBCL patients can be cured by 2-weeks of antibiotics rather than the 6-months of relatively toxic front-line systemic chemotherapy. The investigators shall also elucidate the distribution of CYP2C18/19 in patients with pure (de novo) DLBCL and their association with the efficacy of sequential antibiotics for eradication of Hp infection.
- Conditions
- Gastric Diffuse Large B-cell Lymphoma
- Being tested
- Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
- Keywords
- Helicobactor pylori, Hp, mucosa-associated lymphoid tissue-type lymphoma, MALToma
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole, Amoxicillin, Clarithromycin, MetronidazoleDrug
Also called Anti-H. pylori Therapy
Anti-H. pylori Therapy
| Study group | Role | What they receive |
|---|---|---|
| Anti-H. pylori Therapy | Experimental | Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole Receives: Drug: Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
Measured: 10 years
The median time to pathologic complete remission (months) after completion of antibiotics for Hp-dependent gastric pure (de novo) DLBCL (patients have pCR after Hp eradication therapy [antibiotics])
Measured: 10 years
The relapse-free survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
A nationwide study to prospectively validate
Measured: 10 years
Secondary outcomes (2)
The overall survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
Measured: 10 years
The Hp eradication rate (%)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Diffuse Large B-cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, China Medical University Hospital, Taichung Veterans General Hospital, Changhua Christian Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Kaohsiung Medical University
- Responsible party
- Sponsor
- Investigators
- Sung-Hsin Kuo, MD, PhD., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388581
- Sponsor's protocol ID
- T2214
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Prospective Study of First-line Antibiotic Therapy for Early-stage H. Pylori-Positive Gastric Pure (de Novo) Diffuse Large B-cell Lymphoma and Potential Predicting Factor for Treatment Outcome
- ClinicalTrials.gov ID
- NCT02388581
- Acronym / sponsor ID
- T2214
- Conditions
- Gastric Diffuse Large B-cell Lymphoma
- Keywords
- Helicobactor pylori, Hp, mucosa-associated lymphoid tissue-type lymphoma, MALToma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, China Medical University Hospital, Taichung Veterans General Hospital, Changhua Christian Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Kaohsiung Medical University
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Mar 2015 (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.
Aims: A nationwide study to prospectively validate
- The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
- The durability of complete histological remission after antibiotics
- The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL
- The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in Taiwan.
- The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics.
Detailed description
The study will validate the use of antibiotics as first-line therapy for stage IE (and perhaps IIE-1) Hp-positive gastric pure (de novo) DLBCL. The status of NF-kB, BCL10, BAFF, and CagA IHC nuclear staining will help to tailoring the treatment for early-stage gastric pure (de novo) DLBCL. And 50-60% of stage IE / IIE-1 pure (de novo) DLBCL patients can be cured by 2-weeks of antibiotics rather than the 6-months of relatively toxic front-line systemic chemotherapy. The investigators shall also elucidate the distribution of CYP2C18/19 in patients with pure (de novo) DLBCL and their association with the efficacy of sequential antibiotics for eradication of Hp infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-H. pylori Therapy | Experimental | Drug: Lansoprazole, Amoxicillin, Clarithromycin, MetronidazoleLansoprazole, Amoxicillin, Clarithromycin, Metronidazole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have histologically confirmed H. pylori-positive primary gastric pure (de novo) gastric DLBCL.
- Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL.
- Patients must have evaluable disease by endoscopy and/or by computed tomography.
- Patients must have documented H. pylori infection before treatment, if any of the following test show positive result: histology, rapid urease test (CLO-test), C13 urease breath test, and serology.
- Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
Key exclusion criteria (6 listed)
- Patients with extensive gastrointestinal tract involvement.
- Patients with previous history of extranodal lymphoma.
- Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node.
- Patients with cardiopulmonary status that do not allow repeat endoscopy.
- Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma.
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 |
|---|---|---|
| Lansoprazole, Amoxicillin, Clarithromycin, MetronidazoleAlso: Anti-H. pylori TherapyAnti-H. pylori Therapy | Drug | Anti-H. pylori Therapy |
Primary outcome
The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
Time frame: 10 years
The median time to pathologic complete remission (months) after completion of antibiotics for Hp-dependent gastric pure (de novo) DLBCL (patients have pCR after Hp eradication therapy [antibiotics])
Time frame: 10 years
The relapse-free survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
Time frame: 10 years
A nationwide study to prospectively validate
2 secondary outcomes
The overall survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
Time frame: 10 years
The Hp eradication rate (%)
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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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.
Sung-Hsin Kuo, MD, PhD. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole in people with Gastric Diffuse Large B-cell 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bor-Rong Chen, BS (886-2-26534401 ext. 25162, brong@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2016.