Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006056
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-07-05
Brief Title:
Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic Disorders
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 the efficacy of unrelated donor hematopoietic stem cell transplantation in the treatment of patients with life threatening hemophagocytic disorders
II Determine the rate of disease free survival incidence of graft failure and incidence of graft versus host disease in these patients after undergoing this treatment regimen
II Determine the rate of disease free survival incidence of graft failure and incidence of graft versus host disease in these patients after undergoing this treatment regimen
Detailed Description:
PROTOCOL OUTLINE Patients receive oral busulfan twice a day on days -9 to -6 cyclophosphamide IV over 1 hour on days -5 to -2 etoposide IV over 4 hours on days -5 to -3 and anti-thymocyte globulin IV twice a day on days -2 and -1 and days 1 and 2 Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 Filgrastim G-CSF is administered subcutaneously beginning on day 1 and continuing until blood counts recover Patients receive graft versus host disease prophylaxis with methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1-4 hours orally once the patients resumes eating every 12 hours every 8 hours for pediatric patients starting on or prior to day -3 and continuing up to 1 year
Patients are followed at days 28 and 100 at 6 months and 1 year and then annually for 5 years
Patients are followed at days 28 and 100 at 6 months and 1 year and then annually for 5 years
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-9708 | None | None | None |
| UMN-MT-1997-08 | None | None | None |