skin GVHD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient who receives treatment between April 1st 2018 and March 31st 2023 2. post-allogeneic hematopoietic stem cell transplantation patient with acute or chronic skin GVHD which is refractory to calcineurin inhibitor and/or corticosteroid treatment (not excluding patient who has GVHD in other tissues in addition to skin) 3. Patient who is able to have written informed consent for the study enrollment 4. Age between 16 to 70 at the informed consent 5. No restriction for gender 6. Performance status 0-2 defined by Eastern Cooperative Oncology Group criteria
Exclusion criteria
Exclusion criteria: 1. Pregnant female patient 2. Poor control diabetes mellitus 3. Any severe infection 4. Treatment-difficult skin disease other than GVHD 5. Patients whom an attending physician consider not appropriate for study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates for complete response, partial response, stable disease, and progressive disease 2. Duration of response 3. Sparing effect on calcineurin inhibitor and corticosteroid 4. Adverse event(s) 5. Profile of immune cells | — |
Countries
Japan
Contacts
Kyoto Prefectural University of Medicine Division of Hematology and Oncology