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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00288626
Date of registration: 07/02/2006
Prospective Registration: Yes
Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Public title: High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study
Scientific title: A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis
Date of first enrolment: July 2006
Target sample size: 25
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00288626
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Richard A. Nash, MD
Address: 
Telephone:
Email:
Affiliation:  Blood and Marrow Transplant Program, Colorado Blood Cancer Institute, Presbyterian/St. Luke's Medical Center, Denver
Name:     Uday Popat, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Blood and Marrow Transplantation, University of Texas, M.D. Anderson Cancer Center
Name:     Steven M. Devine, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Hematology and Oncology, Ohio State University Medical Center
Name:     Michael K. Racke, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Neurology, Ohio State University Medical Center
Name:     Annette Wundes, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Neurology, University of Washington
Name:     George H. Kraft, MD
Address: 
Telephone:
Email:
Affiliation:  Departments of Neurology and Rehabilitation Medicine, University of Washington
Name:     George E. Georges, MD
Address: 
Telephone:
Email:
Affiliation:  Fred Hutchinson Cancer Research Center, Clinical Research Division, University of Washington
Name:     James D. Bowen, MD
Address: 
Telephone:
Email:
Affiliation:  Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, Washington
Name:     George J. Hutton, MD
Address: 
Telephone:
Email:
Affiliation:  The Maxine Messinger Multiple Sclerosis Clinic, The Methodist Hospital, Baylor College of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Relapsing-Remitting Multiple Sclerosis
Intervention(s)
Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM)
Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone
Procedure: Autologous hematopoietic stem cell transplant
Primary Outcome(s)
Event-Free Survival Probability During the 5 Years After Transplant [Time Frame: 5 years]
Secondary Outcome(s)
Change From Baseline in Extended Disability Status Scale (EDSS) [Time Frame: 6 months to 5 years after HCT]
Change From Baseline in Number of Gadolinium-Enhanced Lesions [Time Frame: 8 weeks to 5 years after HCT]
Change From Baseline in T1-Weighted Lesion Volume [Time Frame: 8 weeks to 5 years after HCT]
Change From Baseline in T2-Weighted Lesion Volume [Time Frame: 8 weeks to 5 years after HCT]
Disease-Modifying Therapy Survival Probability After Transplant [Time Frame: 1 to 5 years after HCT]
Event-Free Survival Probability After Transplant [Time Frame: 1, 2, and 4 years after HCT]
Event-Free Survival Probability During the 3 Years After Transplant [Time Frame: 3 years]
MRI Activity-Free Survival Probability After Transplant [Time Frame: 1 to 5 years after HCT]
MS Progression-Free Survival Probability After Transplant [Time Frame: 1 to 5 years after HCT]
MS Relapse-Free Survival Probability After Transplant [Time Frame: 1 to 5 years after HCT]
Number of New T2-Weighted Lesions From Baseline [Time Frame: 6 Months to 5 years after HCT]
Overall Survival [Time Frame: From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years]
Percent Change From Screening in Brain Volume [Time Frame: 8 weeks to 5 years after HCT]
Percent of Participants Who Experienced All-Cause Morbidity [Time Frame: From the time of enrollment until completion of the 5-year follow-up, an average of 6 years.]
Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT [Time Frame: From the time of Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) to 1 year after HCT.]
Survival From MS-Related Mortality [Time Frame: From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years]
Survival From Treatment-Related Mortality [Time Frame: From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years]
Time to Neutrophil Engraftment [Time Frame: From time of graft infusion to time of engraftment, up to 6 years]
Time to Platelet Engraftment [Time Frame: From time of graft infusion to time of engraftment, up to 6 years]
Secondary ID(s)
DAIT ITN033AI
DAIT SCMS2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Immune Tolerance Network (ITN)
Ethics review
Results
Results available: Yes
Date Posted: 04/04/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00288626
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