Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010400
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-02-02
Brief Title:
Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
Sponsor:
Johns Hopkins University
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
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 Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide
II Determine the toxicity of this drug in these patients
I Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide
II Determine the toxicity of this drug in these patients
Detailed Description:
PROTOCOL OUTLINE
Patients receive cyclophosphamide IV on days 1-4 and filgrastim G-CSF beginning on day 10 and continuing until blood counts recover
Patients are followed monthly for 6 months and then every 3 months thereafter
Patients receive cyclophosphamide IV on days 1-4 and filgrastim G-CSF beginning on day 10 and continuing until blood counts recover
Patients are followed monthly for 6 months and then every 3 months thereafter
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 |
|---|---|---|---|
| JHOC-97022128 | None | None | None |
| JHOC-J9717 | None | None | None |