Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism
|Rheumatoid Arthritis||Biological: Hematopoietic Stem Cell Transplantation||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism|
- Tender joint count;Swollen joint count; Patient's global assessment of disease;Patient's assessment of pain;Patient's assessment of physical activity; (Health Assessment Questionnaire [HAQ]); Acute phase reactant value (erythrocyte sedimentation rate). [ Time Frame: 5 years after transplant ]
|Study Start Date:||September 2002|
|Study Completion Date:||June 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA
Biological: Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell Transplantation
Peripheral blood stem cell mobilization (PBSC)
PBSC will be mobilized with G-CSF (dose may be adjusted down to 5-10 ug/kg/day by PI for toxicity, e.g. flu-like symptoms) with stem cell collection beginning on day 4 or 5. Leukapheresis may be repeated up to four consecutive days.
Conditioning Regimen Immune Ablation:
Fludarabine 25 mg/m2/d x 5 days (dosage should be based on adjusted body weight) will be given IV over 30 minutes in 100 cc of normal saline.
Cyclophosphamide 50 mg/kg/d x 4 days (dosage should be based on adjusted body weight) will be given IV over 1 hour in 500 cc of normal saline.
CAMPATH-1H 30 mg/day x 3 days (no dose adjustment) will be given IV over 2 hours in 100 cc of normal saline. Premedication with acetaminophen 650mg & benadryl 25-50mg PO/IV will be given 30-60min before infusion. These medications can be repeated as needed.
Hydration approximately 200 cc /hour beginning 6 hours before cyclophosphamide and continued until 24 hours after the last cyclophosphamide dose.
G-CSF will be continued until absolute neutrophil count reaches 1,000 cells/ml for three days.
Cyclosporine will be started at 200 mg po BID and adjusted by HPLC levels to between 150-250 or by toxicity (e.g. tremor, renal insufficiency, TTP, etc.). CSA will be continued for 6 months unless stopped for toxicity
Mycophenolate Mofetil (Cellcept) will be given 1 gram po BID and may be adjusted by toxicity (e.g. cytopenia). Cellcept will be continued for 6 months unless stopped for toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282412
|United States, Illinois|
|Northwestern University, Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Richard Burt, MD||Northwestern University|