Chronic GVHD after hematopoietic stem cell transplantation
Conditions
Interventions
Sponsors
Vorpal Technologies K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who were diagnosed with chronic GVHD according to GVHD guideline after the transplantation of hematopoietic stem cell derived from related donor or unrelated donor. 2. Patients who are judged to be steroid-resistant, steroid-dependent, or steroid-intolerant. 3. Patients who received an explanation for clinical study and submitted a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic or hypersensitive to methoxsalen. 2. Patients who cannot tolerate the changes in blood flow associated with ECP therapy. 3. Patients who are hypersensitive or allergic to both heparin and Acid Citrate Dextrose Solution (ACD) (Patients who are hypersensitive or allergic only one of them are not excluded). 4. Patients who are pregnant, patients who have possibility of being pregnant, or patients who are breastfeeding. 5. Patients who cannot use appropriate contraceptive method throughout the study period. 6. Patients who are infected with human immunodeficiency virus (HIV) or active hepatitis B. 7. Patients with diseases associated with aphakia or photosensitivity (such as systemic lupus erythematosus, porphyria, and albinism) (Non-sighted patients with aphakia are not excluded). 8. Patients who are enrolled in other clinical studies not including a treatment outcome study. 9. Patients with previous experience with ECP therapy. 10. Patients with infectious disease which requires treatment. 11. Patients in whom the blood vessel access is difficult. 12. Patients whose kidney function was worsened within past three months (showing serum creatinine concentration of over 3.0 mg/dL). 13. Patients with life expectancy of less than 6 months. 14. Patients in whom the white blood cell count and platelet count are significantly decreased (white blood cell count of less than 1000/micro L and platelet count of less than 25000/micro L). 15. Patients with Karnofsky Performance Scale of less than 30. 16. Patients with active bleeding in gastrointestinal tract (GI bleeding). 17. Patients who received new drug or increased dose of drug within 14 days for the therapy to treat GVHD. 18. Patients in whom the control of primary disease is difficult. 19. Other patients who are judged by physician as being unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate based on the changes the organ score and the changes in steroid level at prior to ECP therapy and that at Week 24 of ECP therapy. | — |
Countries
Japan
Contacts
Public ContactKohama, Ichiro
Vorpal Technologies K.K. Regulatory Research Development & Quality Managemant
Outcome results
None listed