An investigator initiated phase II clinical trial of Tamibarotene (AM80G) for chronic graft-versus-host disease - A phase II trial of Tamibarotene administration for Chronic GVHD

Okayama University Hospital0 sites18 target enrollmentDecember 27, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: Recipients refractory or resistant chronic GVHD to therapy with corticosteroid
Sponsor: Okayama University Hospital
Enrollment: 18
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

December 27, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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