Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases

Myasthenia Gravis Clinical Trial

Official title: High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a stem cell transplant works in treating patients with autoimmune neurologic disease that did not respond to previous therapy. In autoimmune neurological diseases, the patient's own immune system 'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine, melphalan, and antithymocyte globulin, before a stem cell transplant weakens the immune system and may help stop the immune system from 'attacking' a patient's nervous system. When the patient's own (autologous) stem cells are infused into the patient they help the bone marrow make red blood cells, white blood cells, and platelets so the blood counts can improve.

Clinical Trial Description

OUTLINE:

Patients receive carmustine intravenously (IV) on day -6, etoposide IV and cytarabine IV twice daily (BID) on days -5 to -2, melphalan IV on day -1, and antithymocyte globulin IV on days -2 and -1. Patients then undergo autologous or syngeneic stem cell transplant on day 0. Patients also receive prednisone orally (PO) once daily (QD) on days 7-21, followed by 2 week taper.

After completion of study treatment, patients are followed up at 3 months, 1 year, and then annually thereafter for up to 5 years. ;

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Autoimmune Nervous System Disorder
• Autologous Transplant Autoimmune
• Central Nervous System Vasculitis
• Cerebellar Degeneration
• Chronic Inflammatory Demyelinating Polyneuropathy
• CIDP Transplant
• Encephalitis
• HCT for Neurologic Autoimmune Disorders
• Lambert Eaton Myasthenic Syndrome
• Lambert-Eaton Myasthenic Syndrome
• MS Stem Cell Transplant
• Multiple Sclerosis
• Multiple Sclerosis Stem Cell Transplant
• Multiple Sclerosis Transplant
• Muscle Weakness
• Myasthenia Gravis
• Myasthenia Gravis Transplant
• Myoclonus
• Nervous System Diseases
• Neurologic Autoimmune Disease
• Neuromyelitis Optica
• Ocular Motility Disorders
• Opsoclonus Myoclonus Syndrome
• Opsoclonus-Myoclonus Syndrome
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Rasmussen Subacute Encephalitis
• Sclerosis
• Stiff Person Syndrome
• Stiff-Person Syndrome
• Syndrome
• Vasculitis
• Vasculitis, Central Nervous System

• NCT number: NCT00716066
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2008
• Completion date: January 31, 2030