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Complete 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
|Research Study Number||2260.00|
|Principal Investigator||George Georges, MD|
Research Study Description
We are studying high-dose chemotherapy (drugs called carmustine, etoposide, cytosine arabinoside and melphalan) and antithymocyte globulin, followed by autologous or syngeneic stem cell transplant. (Autologous transplant is a procedure in which a patient receives his or her own stem cells; syngeneic transplant is a procedure in which a patient receives stem cells donated by his or her healthy identical twin.)
Study participants are asked to stay in Seattle for 2-3 months. The first month includes evaluations before treatment begins and the collection of stem cells. Study participants will be admitted to the University of Washington Medical Center to receive the high-dose immunosuppressive therapy and stem cell transplant and initial recovery, about a 3 week stay in the hospital. Following the transplant, participants will have follow-up visits at the Seattle Cancer Care Alliance outpatient clinic for about 1-2 months. Study participants will be expected to remain in Seattle for approximately 2 months after treatment for study follow-up.
When patients leave the transplant center, they will continue to need close follow-up at home with their doctors. Participants will be asked to return to the transplant center annually for 5 years, although this testing can be completed at home.
Diseases included in this study (patients with other related diseases may also be eligible):
Primary CNS Vasculitis
Autoimmune Peripheral Neuropathy
Autoimmune Cerebellar Degeneration
Gait Ataxia with Late Age Onset Polyneuropathy (GALOP)
Stiff Person Syndrome
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Lambert Eaton Myasthenic Syndrome (LEMS)
HTLV-1- Associated Myelopathy (HAM)/ Tropical Spastic Paraparesis (TSP)
Opsoclonus/ Myoclonus (OM ; Anti-Ri)
Neuromyelitis Optica (NMO)
Multiple Sclerosis (MS)
Eligibility Criteria (must meet the following to participate in this study)
2. Diagnosed with an autoimmune disorder of the central or peripheral nervous system
3. Evidence of disease activity
4. Must have had at least 2 previous lines of standard treatment that failed
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
2. Pregnant or planning to become pregnant within 1 year of the procedure
3. Tested positive for HIV antibodies (HIV-positive)
4. Lung, heart, liver or kidney impairment (according to study guidelines)
5. Active uncontrolled infection
6. Evidence of myelodysplasia
Other exclusion criteria may apply.
Autoimmune Diseases; Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Central Nervous System (CNS); Myasthenia Gravis; Non-malignant Condition
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