Gastric Diffuse Large B-cell Lymphoma Clinical Trial
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
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. 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
4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in
Taiwan.
5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp
infection after antibiotics.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: 1. Patients must have histologically confirmed H. pylori-positive primary gastric pure (de novo) gastric DLBCL. 2. Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL. 3. Patients must have evaluable disease by endoscopy and/or by computed tomography. 4. 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. 5. 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. 6. Patients who are either newly diagnosed or already starting anti-H. pylori therapy but not have follow-up endoscopy and biopsy are eligible. 7. 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: 1. Patients with extensive gastrointestinal tract involvement. 2. Patients with previous history of extranodal lymphoma. 3. Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node. 4. Patients with cardiopulmonary status that do not allow repeat endoscopy. 5. Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma. 6. Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Health Research Institutes | Zhunan | Miaoli County |
| Lead Sponsor | Collaborator |
|---|---|
| National Health Research Institutes, Taiwan | Chang Gung Memorial Hospital, Changhua Christian Hospital, China Medical University Hospital, Kaohsiung Medical University, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The pathologic complete remission rate (%) for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL | 10 years | No | |
| Primary | 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]) | 10 years | No | |
| Primary | 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 | 10 years | No |
| Secondary | The overall survival of early-stage Hp-positive gastric pure (de novo) DLBCL who received antibiotics as 1st-line therapy | 10 years | No | |
| Secondary | The Hp eradication rate (%) | 10 years | No |