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

JRCT ID: jRCTs052180005

Registered date:31/10/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Skin GVHD
• Date of first enrollment: 18/12/2018
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Narrow band ultraviolet B(NBUVB) therapy, blood examination

Outcome(s)

• Primary Outcome: Overall response rate
• Secondary Outcome: 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 immune cells, Blood concentrations of inflammatory cytokines

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: KURODA JUNYA