Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006055
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-07-05
Brief Title:
Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
Sponsor:
Fairview University Medical Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine whether there is prompt engraftment after autologous peripheral blood stem cell transplantation using filgrastim G-CSF mobilization in patients with life threatening autoimmune diseases
II Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis high dose cyclophosphamide and total lymphoid irradiation and posttransplant immunosuppression with cyclosporine in these patients
III Determine whether this treatment regimen beneficially influences the clinical course of these patients
II Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis high dose cyclophosphamide and total lymphoid irradiation and posttransplant immunosuppression with cyclosporine in these patients
III Determine whether this treatment regimen beneficially influences the clinical course of these patients
Detailed Description:
PROTOCOL OUTLINE Patients receive filgrastim G-CSF SC daily until peripheral blood stem cells PBSC are collected On the fifth day of G-CSF therapy PBSC are collected Patients undergo plasmapheresis on days -9 to -7 Patients receive cyclophosphamide IV on days -6 to -3 and total lymphoid irradiation on day -1 PBSC are reinfused on day 0 Following PBSC reinfusion patients receive prophylaxis with oral prednisone or methylprednisolone IV on days -1 to 28 antithymocyte globulin IV on days 1-3 and cyclosporine every 12 hours on days 1-60
Patients with autoimmune thrombocytopenia purpura autoimmune hemolytic anemia or pure red cell aplasia are followed on days 7 14 21 28 60 and 100 6 months and 1 2 and 5 years Patients with rheumatoid arthritis juvenile rheumatoid arthritis or systemic lupus erythematosus are followed on days 14 28 60 and 100 and then every 6 months Patients with vasculitis are monitored for abnormal clinical and laboratory parameters characteristic of the individual type of vasculitis
Patients with autoimmune thrombocytopenia purpura autoimmune hemolytic anemia or pure red cell aplasia are followed on days 7 14 21 28 60 and 100 6 months and 1 2 and 5 years Patients with rheumatoid arthritis juvenile rheumatoid arthritis or systemic lupus erythematosus are followed on days 14 28 60 and 100 and then every 6 months Patients with vasculitis are monitored for abnormal clinical and laboratory parameters characteristic of the individual type of vasculitis
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-MT-9615 | None | None | None |
| UMN-MT-1996-15 | None | None | None |