Trial name:FHCRC 2260 CBCI-232
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 Disease
This clinical trial is for patients with central and peripheral nervous system autoimmune disorders, including:
- Stiff Person System
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Multiple Sclerosis
- Myasthenia Gravis
- Primary CNS Vasculitis
- Rasmussen's Encephalitis
- Autoimmune Peripheral Neuropathy
- Autoimmune Cerebellar Degeneration
- Gait Ataxia with Late Age Onset Polyneuropathy (GALOP)
- Lambert Eaton Myasthenic Syndrome
- HTLV-1- Associated Myelopathy (HAM)/ Tropical Spastic Paraparesis (TSP)
- Opsoclonus/ Myoclonus (Anti-Ri)
- Neuromyelitis Optica
- Must be equal to or less than 70 years of age
- Must meet criteria for diagnosis (have been diagnosed by a neurologist)
- Must meet criteria for the severity of the disease (again this is determined by testing and by a neurologist)
- Must have failed at least 2 lines of standard therapy for their specific disease
Contact our New Patient Coordinator at 720-754-4554 for inquiries. She will forward your inquiries to our research department for additional details about this study.
Trial name: Beat-MS (ANTICIPATED TO OPEN LATE 2019/EARLY 2020)
This multi-center randomized controlled trial of 156 participants will compare the treatment strategy of high-dose chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the Best Available Therapy (BAT) for treatment-resistant relapsing-remitting multiple sclerosis (MS).
Who can take part in the Beat-MS study?
The BEAT MS study is open to people with relapsing- remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses. If you have MS that has remained active despite treatment, you may be eligible for the study.
What will the Beat-MS study involve?
During the study, eligible patients will first have their stem cells, which are produced in the bone marrow, collected and frozen. Next, participants will undergo chemotherapy for six days to kill their immune cells. After this, the person's own frozen cells will be returned through an infusion that closely resembles a blood transfusion. "Transplanting" one's own stem cells allows the body to form new immune cells, effectively restoring their immune system. After the transplant, which will be done in the hospital, doctors will watch patients closely for a few weeks. They can expect to be discharged from the hospital around two to three weeks after receiving their stem cells. After discharge, the patient will be followed in the outpatient clinic for a short time, then return to their referring physicians. Over time, the transplanted stem cells multiply and produce new cells to create a healthy immune system. The hope is the transplant resets the patient's immune system so that it stops the inflammation around nerve cells. Though the intensive period of the transplant occurs over about two months, we will be following and collecting data for many years after. In total, patients will be followed for six years.
How is the study being funded?
The National Institute of Health (NIH) is funding the study. The National Institute of Allergy and Infectious Disease (NIAID), one of the 27 institutes making up the NIH, will sponsor the study for BEAT MS. The immune Tolerance Network (ITN) will conduct this study. Patients who undergo transplant on this clinical trial will have this treatment funded by the NIH/ITN. Other clinical trials will be funded by the patient's health insurance.
When will you start recruiting participants?
We will begin enrolling eligible patients when the study opens, which is anticipated to take place in late in early 2020. This website will be updated as soon as the study opens and will include a link to a website to see if you may qualify.
Eligibility Criteria for Beat-MS Study
- Diagnosis of Multiple Sclerosis (MS)
- 18-55 years old
- At least two unique active lesions visible on a brain or spinal cord MRI
- MS must be considered highly active and treatment-resistant relapsing MS with more than two episodes of treatment failure in the two years prior to the screening visit. At least one episode of treatment failure must occur within 12 months prior to the screening visit.
- Insurance or public funding approval
When the study officially opens, this page will be updated with instructions on who to contact if you meet all eligibility requirements.
What is an Autologous Transplant?
It's a transplant where your doctor collects your own stem cells and stores freezes them until your body is ready for transplantation which occurs after receiving conditioning therapy (chemotherapy and immunosuppression).