Dermatomyositis
Conditions
Interventions
Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient diagnosed as dermatomyositis with Performance status (ECOG) 0 to 2, a) Progressive interstitial pneumonia diagnosed by chest X-ray examination or chest CT, %FVC is less than 80% or %DLCO is less than 70%, resistant to treatment with corticosteroids, cyclosporine, cyclophosphamide. b) skin ulcer resistant to treatment with corticosteroids, cyclosporine, cyclophosphamide.
Exclusion criteria
Exclusion criteria: A patient with one of the following severe organ complication, a) Heart: uncontrollable arrhythmia, uncontrollable heart failure, LVEF is less than 50% in cardiac ultrasound examination, moderate or more pulmonary hypertension (mean pulmonary artery pressure is 40 mmHg or more) b) Lung: PaO2 is less than 60 mmHg at room air, %VC is less than 50%. %DLCO is less than 20%. c) Kidney: renal glomerular filtration rate is less than 40 ml/min, serum creatinine is 2 mg/dl or more. d) Uncontrolled malignant neoplasm e) Uncontrollable infection. f) Cyclophosphamide is used more than 10 g in total.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival at 1 year after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival at 1, 3 and 5 years after transplantation %VC at 1, 3 and 5 years after transplantation %DLCO at 1, 3 and 5 years after transplantation Myogenic enzymes at 1, 3 and 5 years after transplantation Number and size of skin ulcers at 1, 3 and 5 years after transplantation Safety, overall survival | — |
Countries
Japan
Contacts
Public ContactHiroki Mitoma
Kyushu University Hospital Department of Clinical Immunology and Rheumatology / Infectious Disease
Outcome results
None listed