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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 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
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032426
Enrollment
40
Registered
2018-09-01
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

Interventions

Narrow band ultraviolet B therapy

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Overall response rate

Secondary

MeasureTime 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

Public ContactJUNYA KURODA

Kyoto Prefectural University of Medicine Division of Hematology and Oncology

junkuro@koto.kpu-m.ac.jp0752515740

Outcome results

None listed

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