acute/chronic graft versus host disease
Conditions
Interventions
Sponsors
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Eligibility
Sex/Gender
Male
Age
0.1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Recipients of primary allogeneic hematopoietic stem cell transplantation (including HLA-compatible or incomplete-compatible allogeneic stem cell transplantation and unrelated donor transplantation); 2. Clinically suspected of acute GVHD grade II-IV, and chronic GVHD grade moderate-severe; 3. Clinical suspicion of steroid-refractory a/cGVHD by the treating physician is also sufficient; 4. Male or female aged 28 days to 18 years; 5. Signed informed consent form before participating in the study.
Exclusion criteria
Exclusion criteria: 1. The primary disease recurred; 2. Uncontrolled active infections, including significant bacterial, fungal, viral or parasitic infections requiring treatment; 3. Severe respiratory diseases; 4. Cholestatic disease, or unrelieved hepatic sinus obstruction syndrome/hepatic vein occlusion;; 5. Patients with end stage renal function (GFR < 15 mL/min). 6. Presence of uncontrolled cardiopulmonary conditions (class III/IV congestive heart failure); 7. Anaphylaxis to any of the components of Ruxolitinib is known; 8. Patients who also participated in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR, PR, OR;OS;NRM;EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| safty; | — |
Countries
China
Contacts
Public ContactQin Maoquan
Study for Ruxolitinib as a Therapy of Pediatric Corticosteroid-Refractory Acute /Chronic Graft-Versus-Host Disease
Outcome results
None listed