Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-01 @ 1:43 AM
Study NCT ID:
NCT00016458
Status:
COMPLETED
Last Update Posted:
2008-09-03
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-09
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 toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis.
II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
Detailed Description:
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and rabbit anti-thymocyte globulin IV over 6-8 hours on days 2-5.
Patients are followed on days 60-85 and then every 3 months for 1 year.
Patients are followed on days 60-85 and then every 3 months for 1 year.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FHCRC-1473.00 | None | None | View |