Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258180
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2005-11-22
Brief Title:
Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy
Status:
COMPLETED
Status Verified Date:
2019-03
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:
RATIONALE Cyclophosphamide may help control the symptoms of autoimmune enteropathy
PURPOSE This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy
PURPOSE This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy
Detailed Description:
OBJECTIVES
Primary
Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide
Secondary
Determine the toxic effects of this drug in these patients
OUTLINE Patients receive cyclophosphamide IV over 1 hour on days 1-4 Patients then receive filgrastim G-CSF IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
After completion of study treatment patients are followed periodically for up to 1½ years
PROJECTED ACCRUAL A total of 7-11 patients will be accrued for this study
Primary
Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide
Secondary
Determine the toxic effects of this drug in these patients
OUTLINE Patients receive cyclophosphamide IV over 1 hour on days 1-4 Patients then receive filgrastim G-CSF IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
After completion of study treatment patients are followed periodically for up to 1½ years
PROJECTED ACCRUAL A total of 7-11 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J0326 | OTHER | None | None |
| J0326 | OTHER | None | None |
| CDR0000441133 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA006973 |