Gastrointestinal MALT lymphomas
Conditions
Interventions
Patients were treated with 4 courses of oral administration of clarithromycin (CAM) 2g/day, once daily, days 1-14, every 21 days.
Sponsors
Iwate Medical University School of Medicine, Division of Gastroenterology, Department of Internal Medicine
Hakodate National Hospita
Okayama University
Hiroshima University
Kyushu University
Hokkaido University
Ibaraki Prefectural Central Hospital
Fukuoka Sanno Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with gastrointestinal MALT lymphoma who is negative for H. pylori infection, or who had not achieved CR at least 6 months after H. pylori eradication. 2) Patients with 20 years or older. 3) Written informed consent was obtained.
Exclusion criteria
Exclusion criteria: 1) Past history of allergy for CAM. 2) Taking drugs contraindicated for concomitant use with CAM, including calcium-channel blockers. 3) Prolonged QTc, sinus bradycardia (HR <50 bpm), or severe atrioventricular block detected by ECG. 4) Past history of gastrectomy. 5) Combined malignancies other than MALT lymphoma. 6) Severe renal dysfunction (eGFR<30 mL/min/1.73m2). 7) Liver dysfunction 8) Pregnant or possible pregnant women. 9) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR), defined as complete remission (CR) and partial remission (PR). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) CR rate after 12, 26 and 52 weeks after the start of this therapy. 2) Progression-free survival after 3 years. 3) Adverse events. | — |
Countries
Japan
Contacts
Public ContactShotaro Nakamura
Iwate Medical University School of Medicine Division of Gastroenterology, Department of Internal Medicine
Outcome results
None listed