Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)
NCT ID: NCT02529839
Last Updated: 2015-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Fludarabine 30mg/m2 for 4 days, Cyclophosphamide 50mg/kg for 2 days, Alemtuzumab administered subcutaneously 24mg total dose.
Autologous bone marrow transplantation
Autologous bone marrow transplantation
IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0
Fludarabine
30mg/m2 on days -6 through -3
Cyclophosphamide
50mg/kg on days -5 through -4
Alemtuzumab
3mg on day -3, 9mg on day -2, 12 mg on day -1
Interventions
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Autologous bone marrow transplantation
IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0
Fludarabine
30mg/m2 on days -6 through -3
Cyclophosphamide
50mg/kg on days -5 through -4
Alemtuzumab
3mg on day -3, 9mg on day -2, 12 mg on day -1
Eligibility Criteria
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Inclusion Criteria
2. Age: 18-65, males and females
3. Relapsing and secondary progressive forms of MS with evidence of significant activity of MS (clinical and on the MRI).
4. EDSS score of 2.0 to 7.0 (see table 1).
5. Failure to at least one line of the currently available treatment, registered treatments (i.e. interferons, Copaxone, Tysabri, Gilenya, Tecfidera, immunosuppression) for MS. The lack of response to these treatments will be determined/defined by either an increase (deterioration) of one degree (or more) in the EDSS score, when baseline EDSS is less than 5.0 or 0.5 degree, when baseline EDSS is 5.0 or more, during the last year or the appearance of one major relapse of MS during the same period of time (under treatment), or evidence for new activity of MS (new T2 lesions or gadolinium enhancing lesions) during the last 12 months.
6. Duration of disease: \>2 years, except cases with rapid progression, i.e. annual relapse rate ≥2 per 2 years on a conventional treatment or malignant multiple sclerosis with very intense symptoms (types is in most cases deadly).
Exclusion Criteria
2. Patients with active infections.
3. Patients with severe cognitive decline or inability to understand and sign the informed consent.
4. Patients who were treated with investigational protocols during the last 3 months prior to the inclusion.
5. Patients who received high dose immunosuppression with autologous stem cell rescue in the past with no effect.
18 Years
65 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Principal Investigators
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Igor Resnick, Prof.
Role: PRINCIPAL_INVESTIGATOR
Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel
Central Contacts
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Other Identifiers
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0105-15-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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