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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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ClinicalTrials.gov Identifier: NCT02529839
Recruitment Status : Unknown
Verified April 2015 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of an immunoablative nonmyeloablative conditioning protocol for autologous bone marrow transplantation in patients with Multiple Sclerosis. Patients meeting inclusion and exclusion criteria will start an immunoablative nonmyeloablative conditioning regimen followed by autologous bone marrow transplantation. Patients will be followed for one year by a neurologist to evaluate the course of the disease after treatment.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: Autologous bone marrow transplantation Drug: Fludarabine Drug: Cyclophosphamide Drug: Alemtuzumab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental

Fludarabine 30mg/m2 for 4 days, Cyclophosphamide 50mg/kg for 2 days, Alemtuzumab administered subcutaneously 24mg total dose.

Autologous bone marrow transplantation

Procedure: Autologous bone marrow transplantation
IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0

Drug: Fludarabine
30mg/m2 on days -6 through -3

Drug: Cyclophosphamide
50mg/kg on days -5 through -4

Drug: Alemtuzumab
3mg on day -3, 9mg on day -2, 12 mg on day -1




Primary Outcome Measures :
  1. Engraftment parameters of Neutrophils and Platelets [ Time Frame: 1 year ]
    Absolute Neutrophil count >500 /microliter, Platelets>20,000/microliter

  2. Transplant related mortality by Day 100 [ Time Frame: Day 100 ]

Secondary Outcome Measures :
  1. Changes in the Expanded Disability Status Scale (EDSS score, as compared to baseline) [ Time Frame: 1 year ]
  2. Overall survival (OS) at 1 year [ Time Frame: 1 year ]
  3. Progression-free survival (PFS) at 1 year [ Time Frame: 1 year ]
  4. Changes in MRI activity [ Time Frame: 1 year ]
    T2 number

  5. Changes in MRI activity [ Time Frame: 1 year ]
    Volume of gadolinium enhancing lesions



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529839


Contacts
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Contact: Igor Resnick, Prof. 972-50-787-4663 gashka.resnick@gmail.com

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Igor Resnick, Prof. Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02529839    
Other Study ID Numbers: 0105-15-HMO-CTIL
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: April 2015
Keywords provided by Hadassah Medical Organization:
MS
BMT
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Fludarabine
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological