High-dose clarithromycin monotherapy for Helicobacter pylori-negative or -eradicated gastrointestinal MALT lymphomas
Phase 2
- Conditions
- Gastrointestinal MALT lymphomas
- Registration Number
- JPRN-UMIN000025831
- Lead Sponsor
- Iwate Medical University School of Medicine, Division of Gastroenterology, Department of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR), defined as complete remission (CR) and partial remission (PR).
- Secondary Outcome Measures
Name Time Method 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.