Steroid-refractory acute Graft-versus-Host disease
Conditions
Interventions
JR-031 is administered 8 times (twice per week for 4 weeks).
Sponsors
JCR pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A patient who is diagnosed with steroid-refractory acute GVHD (which means refractory to either standard therapy according to the guideline of The Japan Society for Hematopoietic Stem Cell Transplantation or steroid pulse therapy), and severity of grade III-IV at the first infusion. 2) A patient aged 6 months or over. 3) A patient who can understand the contents of this trial and can consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) A patient who have already received treatments of any other medications than standard steroid therapy for acute GVHD, except steroid pulse therapy or the prophylactic medications which proceed before the onset of acute GVHD. 2) A patient who has received hematopoietic stem cell transplantation and not in remission of his/her underlying hematopoietic malignancy. (Patients in remission with low risk of early recurrence as predicted by the principal investigator or clinical investigators, are excluded. 3) A patient who has allergy to bovine and/or porcine products. 4) A patient who has severe, uncontrollable infection, such as sepsis. 5) A patient who has highly cardiac dysfunction, pulmonary dysfunction, renal dysfunction or any other hepatic dysfunction than GVHD symptom. 6) A patient who is pregnant or expected or breast-feeding. 7) A patient who is diagnosed with HIV antibody positive, HTLV-I antibody positive, HBs antigen positive or HCV antibody positive, except the HCV antibody positive patient who is diagnosed with HCV-RNA negative, or the HTLV-I antibody positive patient whose underlying disease is ATL. 8) A patient who is diagnosed with uncontorablle hypertension despite treatments. 9) A patient whose PSaO2 is under 94% despite an oxygen administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response which is durable response for 28 consecutive days or more during the period of 24 weeks after the first infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response (OR; CR(Complete Response) or PR(Partial Response)) at the timepoint of 4 weeks after the first infusion. | — |
Countries
Japan
Outcome results
None listed