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

Phase II study of narrow band ultraviolet therapy for treatment-refractory skin graft versus host disease complicated with allogeneic hematopoietic stem cell transplantation - Phase II study of NBUV for skin GVHD

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052180005
Enrollment
40
Registered
2018-10-31
Start date
2018-12-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin GVHD Skin GVHD

Interventions

Narrow band ultraviolet B(NBUVB) therapy, blood examination

Sponsors

KURODA JUNYA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Overall response rate

Secondary

MeasureTime frame
Rates for complete response, partial response, stable disease, and progressive disease, Duration of response, Sparing effect on calcineurin inhibitor and corticosteroid, Adverse event(s), Profile of white blood cells, blood biochemical data

Contacts

Public ContactJUNYA KURODA

University Hospital Kyoto Prefectural University of Medicine

junkuro@koto.kpu-m.ac.jp+81-75-251-5740

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026