- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264822
Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fukuoka, Japan
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Hiroshima, Japan
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Kyoto, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Saga, Japan
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Tottori, Japan
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Toyama, Japan
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Yamaguchi, Japan
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Aichi
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Nagoya, Aichi, Japan
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Aomori
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Hirosaki, Aomori, Japan
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Chiba
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Kashiwa, Chiba, Japan
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Ehime
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Matsuyama, Ehime, Japan
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Hiroshima
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Fukuyama, Hiroshima, Japan
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Hokkaido
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Sapporo, Hokkaido, Japan
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Hyogo
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Amagasaki-shi, Hyogo, Japan
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Kobe, Hyogo, Japan
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Ibaraki
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Hitachi, Ibaraki, Japan
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Kagawa
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Takamatsu, Kagawa, Japan
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Kanagawa
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Isehara, Kanagawa, Japan
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Miyagi
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Sendai, Miyagi, Japan
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Nagano
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Nagano-shi, Nagano, Japan
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Suzaka, Nagano, Japan
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Oita
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Oita-shi, Oita, Japan
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Yufu, Oita, Japan
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Okayama
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Kurashiki, Okayama, Japan
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Tsuyama, Okayama, Japan
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Osaka
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Hirakata, Osaka, Japan
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Osakasayama, Osaka, Japan
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Takatsuki, Osaka, Japan
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Shimane
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Matsue, Shimane, Japan
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Shizuoka
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Hamamatsu, Shizuoka, Japan
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Tochigi
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Otawara-shi, Tochigi, Japan
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Tokyo
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Chuo, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Yamagata
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Yamagata-shi, Yamagata, Japan
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Yamaguchi
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Ube, Yamaguchi, Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive
- The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5
Exclusion criteria:
- With diffuse large B-cell lymphoma
- Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
- Corresponding to contraindication of each drug
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Treatment Arm 1 Rabeprazole Sodium
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The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg. The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily. If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori
Time Frame: Every 3 months within the 1st year and every 6 months
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Every 3 months within the 1st year and every 6 months
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Transition rate to secondary therapy for eradication of Helicobacter pylori
Time Frame: Every 6 months within the 1st year and every 12 months as needed
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Every 6 months within the 1st year and every 12 months as needed
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Katsuya Sugizaki, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Lymphoma, B-Cell
- Lymphoma
- Stomach Neoplasms
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell, Marginal Zone
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Rabeprazole
Other Study ID Numbers
- PRT10T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive
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Wonkwang University HospitalRecruitingHelicobacter Pylori-positive With Functional DyspepsiaKorea, Republic of
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Chuncheon Sacred Heart HospitalCompletedGastric Ulcer Associated With Helicobacter PyloriKorea, Republic of
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Fudan UniversityRecruitingHelicobacter Pylori Infection | MALT Lymphoma of StomachChina
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Xiuli ZuoActive, not recruitingEarly Gastric Cancer | Gastric Cancer | Helicobacter Pylori Infection | Intestinal Metaplasia | Atrophic Gastritis | Low Grade Intraepithelial Neoplasia | High Grade Intraepithelial NeoplasiaChina
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TakedaCompletedGastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and OtherJapan
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Mayo ClinicNational Cancer Institute (NCI)RecruitingRecurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Recurrent Diffuse Large B-Cell... and other conditionsUnited States
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Asan Medical CenterNational Evidence-Based Healthcare Collaborating AgencyUnknownLymphoma | Gastritis | Gastric Cancer | Peptic Ulcer | Helicobacter Pylori InfectionKorea, Republic of
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Novartis VaccinesCompletedLymphoma | Gastritis | Gastric Cancer | Helicobacter Pylori | Gastroduodenal UlcersGermany
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Atara BiotherapeuticsRecruitingHigh-grade B-cell Lymphoma | MCL | Diffuse Large B-cell Lymphoma (DLBCL) | Relapsed/Refractory B-cell Non-Hodgkin Lymphoma | DLBCL/High-grade B-cell Lymphoma With MYC and BCL2 Rearrangements | Anaplastic Lymphoma Kinase-Positive Large B-Cell Lymphoma | LBCL With IRF4 Rearrangement | High-grade B-cell... and other conditionsUnited States
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Shanghai Henlius BiotechWithdrawnCD20-positive Follicular Lymphoma, With Low Tumour Burden
Clinical Trials on Rabeprazole Sodium
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Johnson & Johnson Pharmaceutical Research & Development...Completed
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Johnson & Johnson Pharmaceutical Research & Development...Completed
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Eisai Co., Ltd.Completed
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Eisai Inc.CompletedSymptomatic Gastroesophageal Reflux Disease (sGERD)United States
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Janssen Research & Development, LLCEisai Inc.CompletedGastroesophageal Reflux Disease (GERD)United States, Poland, United Kingdom, Belgium, Brazil
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Yungjin Pharm. Co., Ltd.Seoul National University HospitalCompletedGastroesophageal Reflux DiseaseKorea, Republic of
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Johnson & Johnson Pharmaceutical Research & Development...Eisai Inc.CompletedGastroesophageal RefluxUnited States, Belgium, Israel, Poland, Australia, Netherlands, South Africa, Hungary, Bulgaria, Denmark
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Zeria PharmaceuticalCompleted
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Zeria PharmaceuticalCompleted
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Sihuan Pharmaceutical Holdings Group Ltd.Completed