Back to resultsFirst-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL
Primary Purpose
Gastric Diffuse Large B-cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Diffuse Large B-cell Lymphoma focused on measuring Helicobactor pylori, Hp, mucosa-associated lymphoid tissue-type lymphoma, MALToma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Health Research InstitutesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-H. pylori Therapy
Arm Description
Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Outcomes
Primary Outcome Measures
The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
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])
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
Secondary Outcome Measures
The overall survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
The Hp eradication rate (%)
Full Information
NCT ID
NCT02388581
First Posted
December 4, 2014
Last Updated
March 23, 2016
Sponsor
National Health Research Institutes, Taiwan
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
1. Study Identification
Unique Protocol Identification Number
NCT02388581
Brief Title
First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Diffuse Large B-cell Lymphoma
Keywords
Helicobactor pylori, Hp, mucosa-associated lymphoid tissue-type lymphoma, MALToma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-H. pylori Therapy
Arm Type
Experimental
Arm Description
Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Intervention Type
Drug
Intervention Name(s)
Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Other Intervention Name(s)
Anti-H. pylori Therapy
Intervention Description
Anti-H. pylori Therapy
Primary Outcome Measure Information:
Title
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
Title
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
Title
The relapse-free survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
Description
A nationwide study to prospectively validate
Time Frame
10 years
Secondary Outcome Measure Information:
Title
The overall survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy
Time Frame
10 years
Title
The Hp eradication rate (%)
Time Frame
10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bor-Rong Chen, BS
Phone
886-2-26534401
Ext
25162
Email
brong@nhri.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Hsin Kuo, MD, PhD.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Research Institutes
City
Zhunan
State/Province
Miaoli County
ZIP/Postal Code
35053
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
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First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL
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