Phase II study of NBUVB for treatment-refractory skin GVHD complicated with allogeneic hematopoietic stem cell transplantatio

Phase 2

Recruiting

• Conditions: Skin GVHD

• Registration Number: JPRN-jRCTs052180005
• Lead Sponsor: KURODA JUNYA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patient who receives treatment between the date of jRCT release and March 31st 2026
2. Post-allogeneic hematopoietic stem cell transplantation patient with treatment-refractory acute skin GVHD which is defined by the disease status which is not improved by 5 days treatment with corticosteroid.
3. Patient with acute skin GVHD which is histologically diagnosed.
4. Grade I to II acute GVHD
5. Patient who is able to have written informed consent for the study enrollment
6. Age between 16 to 70 at the informed consent
7. No restriction for gender
8. Both outpatient and inpatient are eligible
9. Performance status 0-2 defined by Eastern Cooperative Oncology Group 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 with Grade 3 or worse GVHD
6. Patients with photodermatosis, or those take drugs which may cause photodermatosis
7. Patients whom an attending physician consider not appropriate for study enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified