Study of evaluating T cells subsets and cytokines in Phase II clinical trial of Tamibarotene (AM80G) for chronic graft-versus-host disease
- Conditions
- Recipients refractory or resistant chronic GVHD to therapy with corticosteroid
- Registration Number
- JPRN-UMIN000020364
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 18
Not provided
1. Mental illness which needs psychiatric medication or are judged by physician as being unsuitable 2. Active, uncontrolled infection (not responding to antibiotics, antifungal or antiviral therapies) 3. Patients with severe liver dysfunction (CTCAE ver.4.0 Grade 3 or more, excepting liver GVHD) 4. Patients with previous experience with Am80 or other retinoid in the past 12 weeks 5. Patients who are allergic or hypersensitive to Am80 or other retinoid. 6. Patients who are pregnant, patients who have possibility of being pregnant, or patients who are breastfeeding. 7. Pulmonary: DLCO <40% or FEV1% <40% 8. Patients with life expectancy of less than 6 months. 9. Patients who are enrolled in other clinical studies in the past 3 months. 10. Other patients who are judged by physician as being unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method