Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282412
Status:
TERMINATED
Last Update Posted:
2018-07-30
First Post:
2006-01-24
Brief Title:
Rheumatoid ArthritisTolerance Induction by Mixed Chimerism
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Rheumatoid Arthritis Tolerance Induction by Mixed Chimerism
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participant enrolled for three years No plan to continue study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rheumatoid arthritis disease is believed to be due to immune cells cells that normally protect the body and are now causing damage to the body Risk of death is highest in people with twenty or more joints actively involved with disease positive rheumatoid factor an elevated sedimentation rate laboratory measures of active inflammation and patients with limitation of daily activities trouble doing simple things like opening a carton of milk In these high risk patients life is significantly shortened Death is usually from heart disease kidney failure neck dislocation broken hip bones or blood clots to the lung In this study we use moderate dose chemotherapy cyclophosphamide and fludarabine and CAMPATH-1H a protein that kills the immune cells that are thought to be causing the disease followed by infusion of blood stem cells that have been collected from the patients brother or sister allogeneic stem cell transplant The purpose of the moderate dose chemotherapy and CAMPATH-1H is to destroy the cells in the immune system and to allow the cells from the patients brother or sister to grow The purpose of the stem cell infusion is to restore blood cell production which will be severely impaired by the moderate dose chemotherapy and CAMPATH-1H and to produce a normal immune system that will no longer attack the body
Detailed Description:
Peripheral blood stem cell mobilization PBSC
PBSC will be mobilized with G-CSF dose may be adjusted down to 5-10 ugkgday by PI for toxicity eg 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 mgm2d 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 mgkgd 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 mgday 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 POIV 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 1000 cellsml for three days
Cyclosporine will be started at 200 mg po BID and adjusted by HPLC levels to between 150-250 or by toxicity eg 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 eg cytopenia Cellcept will be continued for 6 months unless stopped for toxicity
PBSC will be mobilized with G-CSF dose may be adjusted down to 5-10 ugkgday by PI for toxicity eg 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 mgm2d 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 mgkgd 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 mgday 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 POIV 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 1000 cellsml for three days
Cyclosporine will be started at 200 mg po BID and adjusted by HPLC levels to between 150-250 or by toxicity eg 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 eg cytopenia Cellcept will be continued for 6 months unless stopped for toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None