Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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31 August 2015 |
Main ID: |
NCT02529839 |
Date of registration:
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10/06/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)
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Scientific title:
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Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis |
Date of first enrolment:
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October 2015 |
Target sample size:
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20 |
Recruitment status: |
Not yet recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02529839 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Contacts
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Name:
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Igor Resnick, Prof. |
Address:
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Telephone:
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972-50-787-4663 |
Email:
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gashka.resnick@gmail.com |
Affiliation:
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Name:
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Igor Resnick, Prof. |
Address:
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Telephone:
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Email:
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Affiliation:
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Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Consenting patients fulfilling the Poser's clinical criteria for definite MS
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:
1. Patients suffering from significant cardiac, renal or hepatic failure or any other
disease that may risk the patient or interfere with the ability to undergo high dose
immunosuppression associated toxicities (according to the existing limitations for
autologous transplantation).
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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Alemtuzumab
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Drug: Fludarabine
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Procedure: Autologous bone marrow transplantation
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Drug: Cyclophosphamide
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Primary Outcome(s)
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Transplant related mortality by Day 100
[Time Frame: Day 100]
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Engraftment parameters of Neutrophils and Platelets
[Time Frame: 1 year]
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Secondary Outcome(s)
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Overall survival (OS) at 1 year
[Time Frame: 1 year]
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Changes in the Expanded Disability Status Scale (EDSS score, as compared to baseline)
[Time Frame: 1 year]
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Progression-free survival (PFS) at 1 year
[Time Frame: 1 year]
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Changes in MRI activity
[Time Frame: 1 year]
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Secondary ID(s)
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0105-15-HMO-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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