Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017628
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-06-06
Brief Title:
Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
Sponsor:
Northwestern Memorial Hospital
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 efficacy in terms of disease progression of high-dose cyclophosphamide and total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in patients with multiple sclerosis
I Determine the efficacy in terms of disease progression of high-dose cyclophosphamide and total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in patients with multiple sclerosis
Detailed Description:
PROTOCOL OUTLINE Following an induction course of cyclophosphamide IV patients receive filgrastim G-CSF subcutaneously SC daily until the completion of peripheral blood stem cell PBSC harvesting PBSCs are collected over several days Patients who do not mobilize sufficient cells undergo bone marrow harvest Harvested PBSCs or bone marrow then undergo T-lymphocyte depletion
Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 and methylprednisolone IV daily on days -4 to -1 Patients also undergo total body irradiation twice a day on days -4 to -1 Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0 Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts have recovered for 3 days
Patients are followed at 1 2 3 6 and 12 months and then annually for 5 years
Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 and methylprednisolone IV daily on days -4 to -1 Patients also undergo total body irradiation twice a day on days -4 to -1 Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0 Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts have recovered for 3 days
Patients are followed at 1 2 3 6 and 12 months 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 |
|---|---|---|---|
| NU-95MS1 | None | None | None |