drugset / Trial / NCT00787722

Hematopoietic Stem Cell Transplant in Devic's Disease

NCT00787722

Phase 1/2 Completed 13 enrolled Northwestern University
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to examine whether treating Devic's disease patients with high dose cyclophosphamide together with rabbit antithymocyte globulin (rATG)/rituximab (drugs which reduce the function of the immune system), followed by return of previously collected patient's stem cells will result in improvement in Devic's disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in patient's immune system, which may be causing his/her disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack patient's body. The purpose of study is to examine the safety and efficacy of this treatment. The drugs used in this study treatment are drugs for commonly used for immune suppression.

Timeline

Start
2009-10-10
Primary completion
2018-11
Completion
2018-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 500 mg
Subject rATG Protein / enzyme biologic 1.5 mg/kg
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule
Background G-CSF Protein / enzyme biologic 5 ug/kg
Background G-CSF Protein / enzyme biologic 10 ug/kg
Background Methylprednisolone Other / unclassified

Indications