Status:
COMPLETED
High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effectiveness of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal cord. MS can be pr...
Detailed Description
MS is a chronic autoimmune disease of the central nervous system in which myelin, the protective coat that surrounds nerve cells, is damaged or destroyed by autoimmune T cells and macrophages, leading...
Eligibility Criteria
Inclusion
- Diagnosis of relapsing-remitting or progressive-relapsing multiple sclerosis for less than 15 years using McDonald Criteria. More information on this criterion can be found in the protocol
- Score between 3.0 and 5.5 on the Expanded Disability Status Scale (EDSS)
- T2 abnormalities on brain MRI consistent with MS
- Two or more relapses in 18 months time on interferon (IFN), glatiramer acetate (GA), natalizumab or cytotoxic therapy with EDSS increase of 1.0 or greater for participants with EDSS at screening of 3.0 to 3.5 (0.5 or greater for participants with EDSS at screening of 4.0 to 5.5) sustained at least 4 weeks after at least one of these relapses OR one relapse on IFN, GA, natalizumab or cytotoxic therapy with EDSS increase of 1.5 or greater (1.0 for subjects with EDSS at screening of 5.5) sustained at least 4 weeks, together with MRI changes consistent with poor prognosis. More information on this criterion can be found in the protocol.
- On IFN or GA for at least 6 months before the relapses occur that are counted to satisfy previous inclusion criterion OR have received adequate doses of natalizumab or cytotoxic therapy on a treatment schedule before the relapses occur that are counted to satisfy previous inclusion criterion
- Approval by an MS Review Panel to participate in the study. More information on this criterion can be found in the protocol
- In good clinical condition with adequate organ function and without coexisting medical problems that would increase the risk to the participant
- Willing to use acceptable methods of contraception
- Willing and able to comply with all study requirements and
- Willing to accept and comprehend irreversible sterility as side effect of therapy.
Exclusion
- Primary progressive MS
- Secondary progressive MS without relapses (i.e., progression without exacerbations or relapses) for 12 or more months
- Neuromyelitis optica, a disease similar to MS
- Initiation of new immunosuppressant treatment after the participant becomes eligible for the protocol or continuance of immunosuppressant drugs after the participant is screened for the protocol. Treatment with IFN, GA, or corticosteroids is permitted after the participant becomes eligible for the protocol.
- Lapse of greater than 6 months between the time a participant is eligible for the protocol and initiation of protocol treatment except when judged acceptable by the MS Review Panel
- Prior treatment with investigational immunosuppressive agents within 3 months of study eligibility
- Positive baseline plasma and CSF testing for JC virus or a brain MRI that has changes consistent with a diagnosis of progressive multifocal encephalopathy (PML)
- History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS)
- Active hepatitis B or C infection, cirrhosis, or HIV infection
- Uncontrolled diabetes mellitus
- Uncontrolled viral, fungal, or bacterial infection. Patients with asymptomatic bacteriuria are not excluded
- Any illness that would jeopardize the ability to tolerate aggressive chemotherapy
- Prior history of malignancy, except localized basal cell or squamous skin cancer. Other malignancies for which the subject is judged cured by the administered therapy will be considered on an individual basis.
- Hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins or to iron compounds/medications
- Metallic objects implanted in the body that would affect MRI exams
- Psychiatric illness, mental deficiency, or cognitive dysfunction or
- Pregnancy.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00288626
Start Date
July 1 2006
End Date
November 1 2015
Last Update
September 19 2017
Active Locations (4)
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1
Ohio State University School of Medicine
Columbus, Ohio, United States, 43210
2
Baylor College of Medicine
Houston, Texas, United States, 77030
3
M.D. Anderson Cancer Center; Transplant site, please contact Baylor College of Medicine
Houston, Texas, United States, 77230-1402
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024