Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism
|ClinicalTrials.gov Identifier: NCT00282412|
Recruitment Status : Terminated (No participant enrolled for three years. No plan to continue study.)
First Posted : January 26, 2006
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Hematopoietic Stem Cell Transplantation Drug: Fludarabine Drug: Cyclophosphamide Drug: Campath 1H Drug: GCSF Drug: Cyclosporins Drug: Mycophenolate Mofetil||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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
inhibits DNA synthesis or repair
Other Name: Fludara
Causes prevention of cell division by forming adducts with DNA
Other Name: Cytoxan, Neosar
Drug: Campath 1H
humanized monoclonal antibody against CD52 antigen
Other Name: Alemtuzumab
Hematopoietic growth factor
Other Name: Neupogen
immune suppressive drug
Other Name: CSA
Drug: Mycophenolate Mofetil
immune suppressive drug
Other Name: Cellcept
- Survival [ Time Frame: up to 5 years ]The number of participants who survived treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282412
|United States, Illinois|
|Northwestern University, Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Richard Burt, MD||Northwestern University|