NCT00017628

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Northwestern Memorial Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 59 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	cyclophosphamide
DRUG	filgrastim
DRUG	methylprednisolone
PROCEDURE	Autologous Stem Cell Transplantation

Timeline

• Start date: 2001-04-01
• First posted: 2001-06-06
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States