Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases
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- STATUS
- Recruiting
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- End date
- Jun 30, 2033
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- participants needed
- 80
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- sponsor
- Fred Hutchinson Cancer Center
Summary
This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a peripheral blood 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 peripheral blood 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.
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 peripheral blood 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.
Details
| Condition | Autoimmune Disease, Neurologic Autoimmune Disease, Autologous Transplant Autoimmune, Multiple Sclerosis Transplant, MS Stem Cell Transplant, Multiple Sclerosis Stem Cell Transplant, Stiff Person Syndrome, HCT for Neurologic Autoimmune Disorders, CIDP Transplant, Myasthenia Gravis Transplant, Autoimmune Nervous System Disorder, Central Nervous System Vasculitis, Cerebellar Degeneration, Chronic Inflammatory Demyelinating Polyneuropathy, Lambert Eaton Myasthenic Syndrome, Myasthenia Gravis, Neuromyelitis Optica, Opsoclonus Myoclonus Syndrome, Rasmussen Subacute Encephalitis |
|---|---|
| Treatment | anti-thymocyte globulin, laboratory biomarker analysis, cytarabine, etoposide, prednisone, melphalan, autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, carmustine, Syngeneic Bone Marrow Transplantation |
| Clinical Study Identifier | NCT00716066 |
| Sponsor | Fred Hutchinson Cancer Center |
| Last Modified on | 11 July 2022 |
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