Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014755
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-04-10
Brief Title:
Phase I Pilot Study of Total-Body Irradiation Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-04
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 total-body irradiation anti-thymocyte globulin and cyclophosphamide followed by syngeneic or autologous peripheral blood stem cell PBSC transplantation in patients with multiple sclerosis
II Determine the disease response of patients treated with this regimen III Determine the safety and efficacy of filgrastim G-CSF for PBSC mobilization in this patient population
II Determine the disease response of patients treated with this regimen III Determine the safety and efficacy of filgrastim G-CSF for PBSC mobilization in this patient population
Detailed Description:
PROTOCOL OUTLINE This is a multicenter study Patients receive oral prednisone on days 0-10 Beginning on day 1 patients undergoing autologous peripheral blood stem cell PBSC transplantation receive filgrastim G-CSF subcutaneously daily until leukapheresis is completed Leukapheresis begins on approximately day 4 and continues until adequate CD34 PBSC are collected
PBSC are collected from syngeneic donors in a similar manner Patients undergo total-body irradiation twice daily on days -5 and -4 Patients receive cyclophosphamide IV on days -3 and -2 and anti-thymocyte globulin IV on days -5 -3 -1 1 3 and 5 Patients undergo autologous or syngeneic PBSC transplantation on day 0 Following PBSC transplantation patients receive oral prednisone on days 7-30 and G-CSF IV daily beginning on day 0 and continuing until blood counts recover
Patients are followed at 30 80 and 90 days monthly for 6 months and then at 1 and 2 years
PBSC are collected from syngeneic donors in a similar manner Patients undergo total-body irradiation twice daily on days -5 and -4 Patients receive cyclophosphamide IV on days -3 and -2 and anti-thymocyte globulin IV on days -5 -3 -1 1 3 and 5 Patients undergo autologous or syngeneic PBSC transplantation on day 0 Following PBSC transplantation patients receive oral prednisone on days 7-30 and G-CSF IV daily beginning on day 0 and continuing until blood counts recover
Patients are followed at 30 80 and 90 days monthly for 6 months and then at 1 and 2 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 |
|---|---|---|---|
| FHCRC-116400 | None | None | None |