Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004643
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
Last Known Status:
None
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 Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus
II Evaluate objective disease parameters including serum complement levels anti-DNA antibody titers sedimentation rate and the systemic lupus activity measure in these patients
II Evaluate objective disease parameters including serum complement levels anti-DNA antibody titers sedimentation rate and the systemic lupus activity measure in these patients
Detailed Description:
PROTOCOL OUTLINE
Subcutaneous cytarabine is given for 5 days Patients are re-treated every 4 weeks for a maximum of 3 courses those who relapse prior to the second course are re-treated every 3 weeks
Subcutaneous cytarabine is given for 5 days Patients are re-treated every 4 weeks for a maximum of 3 courses those who relapse prior to the second course are re-treated every 3 weeks
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 |
|---|---|---|---|
| UMMC-91208 | None | None | None |