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Trial record 12 of 75 for:    multiple sclerosis stem cell

Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) (BEAT-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047628
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio.

All participants will be followed for 72 months after randomization (Day 0, Visit 0).


Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Relapsing Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Procedure: Autologous Hematopoietic Stem Cell Transplantation Biological: Best Available Therapy (BAT) Phase 3

Detailed Description:

Participant recruitment for this six-year research study focuses on multiple sclerosis (MS) that has remained active despite treatment. This study will compare high dose immunosuppression followed by autologous hematopoietic stem cell transplantation (AHSCT) to best available therapy (BAT) in the treatment of relapsing MS.

MS is a disease caused by one's own immune cells. Normally, immune cells fight infection. In MS, immune cells called T cells, or chemical products made by immune cells, react against the covering or coat (myelin) of nerve fibers in the brain and spinal cord. This leads to stripping the coat from certain nerve fibers (demyelination), and this causes neurologic problems. MS can cause loss of vision, weakness or incoordination, loss or changes in sensation, problems with thinking or memory, problems controlling urination, and other disabilities.

Most individuals with MS first have immune attacks (called relapses) followed by periods of stability. Over time, MS can have episodes of new and worsening symptoms, ranging from mild to disabling. This is called relapsing MS. Relapsing MS includes relapsing remitting MS (RRMS) and secondary progressive MS (SPMS). There are medicines (drugs) to decrease relapses, but these are neither considered to be curative nor, to induce prolonged remissions without continuing therapy.

More than a dozen medicines have been approved for the treatment of relapsing forms of MS. These medicines differ in how safe they are and how well they work. Despite availability of an increasing number of effective medicines, some individuals with relapsing MS do not respond to treatment. Research is being conducted to find other treatments.

High dose immunosuppression followed by autologous hematopoietic stem cell transplantation (AHSCT) has been shown to help relapsing MS in cases where medicines did not work. AHSCT involves collecting stem cells, which are produced in the bone marrow. These stem cells are "mobilized" to leave the bone marrow and move into the blood where they can be collected and stored. Participants will then receive chemotherapy intended to kill immune cells. One's own stored (frozen) stem cells are then given back, through an infusion. This "transplant" of one's stem cells allows the body to form new immune cells in order to restore their immune system. New research suggest that MS might be better controlled with AHSCT than with medicines.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : November 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AHSCT

AHSCT: Myeloablative and Immunoablative therapy followed by Autologous Hematopoietic Stem Cell Transplantation

Participants will undergo:

  1. Mobilization and graft collection: mobilization of peripheral blood stem cells (PBSC) with cyclophosphamide, filgrastim, and dexamethasone. The autologous graft will be collected by leukapheresis and cryopreserved.
  2. Conditioning: high dose myeloablative and immunoablative conditioning with a six-day BEAM chemotherapy and rabbit anti-thymocyte globulin regimen will be initiated ≥30 days after cyclophosphamide mobilization.
  3. Autologous cryopreserved graft infusion: the cryopreserved peripheral blood stem cells (PBSC) graft will be thawed and infused the day following completion of the conditioning regimen. Each bag will be thawed and infused according to institutional standards consistent with the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines. Participants will receive prednisone following graft infusion.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
  1. PBSC mobilization & collection regimen per protocol/ institutional standards includes: intravenous cyclophosphamide (Cytoxan®), 4 grams/m^2); intravenous mesna (Mesnex®),a total delivery of 4 grams/m^2); oral dexamethasone, 10 mg dose, four times daily); subcutaneous filgrastim,10 mcg/kg/day until leukapheresis goal is completed; and CD34+ peripheral blood stem cells collection by leukapheresis.
  2. Conditioning per protocol& institutional standards:

    • 6-day BEAM (e.g. Carmustine (BCNU), Etoposide (VP-16), Cytarbine (Ara-C), and Melphalan) chemotherapy protocol and,
    • rabbit anti-thymocyte globulin (rATG) 2.5 mg/kg/day x2
  3. Autologous cryopreserved graft infusion: The target Cluster of Differentiation (CD)34+ cell dose for infusion is 5 x 10^6 CD34+ cells/kg (minimum 4 x 10^6 CD34+ cells/kg; maximum 7.5 x 10^6 CD34+ cells/kg).

For 1&2 above: Ideal body weight (IBW) versus Actual Body Weight (ABW) are applicable.

Other Name: AHSCT

Active Comparator: Best Available Therapy (BAT)
Participants randomized to BAT: Best available therapy will be selected by the Site Investigator from: natalizumab (Tysabri®), alemtuzumab (Campath®, Lemtrada®), ocrelizumab (Ocrevus®), or rituximab (Rituxan®).
Biological: Best Available Therapy (BAT)

Disease-modifying therapy (DMT) selected by the Site Investigator from the below:

  • natalizumab
  • alemtuzumab
  • ocrelizumab, or
  • rituximab
Other Names:
  • natalizumab (Tysabri®)
  • alemtuzumab (Campath®, Lemtrada®)
  • ocrelizumab (Ocrevus®)
  • rituximab (Rituxan®)




Primary Outcome Measures :
  1. Multiple Sclerosis (MS) Relapse-Free Survival [ Time Frame: From Day 0 (Randomization to Treatment) Up to 36 Months (3 Years) ]
    MS relapse-free survival, analyzed as time from treatment randomization until MS relapse or death from any cause.


Secondary Outcome Measures :
  1. Number of Multiple Sclerosis (MS) Relapses Per Year [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]
    Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year.

  2. The Occurrence of Any Evidence of Multiple Sclerosis (MS) Disease Activity or Death From Any Cause [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]
    The occurrence of any evidence of MS disease activity or death from any cause, analyzed as time-to-event.

  3. The Occurence of Confirmed Disability Worsening by the Kurtz Expanded Disability Status Scale (EDSS) [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]

    Measured by the Kurtzke Expanded Disability Status Scale performed by the masked (blinded) rater.

    EDSS, defined by:

    • A decrease in EDSS of ≥ 1.0 step(s) compared to the EDSS at randomization (Day 0) and
    • Confirmation of disability improvement ≥ 6 months later. The time of confirmed disability worsening measured by EDSS will be the time of first increase in EDSS ≥ 1.0 step(s).

  4. The Occurrence of Confirmed Disability Improvement by the Kurtz Expanded Disability Status Scale (EDSS) [ Time Frame: Day 0 (Randomization to Treatment) Up to Month 72 (6 Years) ]

    Measured by the Kurtzke Expanded Disability Status Scale performed by the masked (blinded) rater.

    Confirmed disability improvement defined by:

    • A decrease in EDSS of ≥ 1.0 step(s) compared to the EDSS at randomization (Day 0) and
    • Confirmation of disability improvement ≥ 6 months later. The time of confirmed disability improvement measured by EDSS will be the time of first decrease in EDSS ≥ 1.0 step(s).

  5. Change from Day 0 in Whole Brain Volume [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]
    Method of assessment: Magnetic Resonance Imaging (MRI) imaging.

  6. Change in Serum Neurofilament Light Chain (NfL) Concentration [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]
    Extent of neurofilament light chain (NfL) concentration in serum is a component of the neuronal cytoskeleton and is released into the cerebrospinal fluid and subsequently blood following neuro-axonal damage.

  7. The Occurrence of Death From Any Cause: All-Cause Mortality [ Time Frame: Day 0 (Randomization to Treatment) Up to Month 72 (6 Years) ]
    Any death, regardless of relationship to treatment.

  8. Proportion of Participants who Experience a Serious Adverse Event (SAE) [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]

    An event that results in any of the following outcomes:

    • Death,
    • A life-threatening event that places the participant at immediate risk of death,
    • Inpatient hospitalization or prolongation of existing hospitalization,
    • Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or
    • A congenital anomaly or birth defect.

      • Note: Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

    Reference: Code of Federal Regulations Title 21 Part 312.32(a)


  9. Proportion of Participants with a Grade 3 or Higher Infection [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]
    In accordance with the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events NCI-CTCAE version 5.0, published November 27, 2017.

  10. Proportion of Participants with Progressive Multifocal Leukoencephalopathy (PML) [ Time Frame: From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years) ]

    The occurrence of PML during the course of participation in this study.

    A disease of the white matter of the brain, caused by a virus infection, Polyomavirus JC (JC virus), that targets cells that make myelin--the material that insulates nerve cells (neurons).


  11. Time to Neutrophil Engraftment Among Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Recipients [ Time Frame: From Day of Graft Infusion (Receipt of Peripheral Blood Stem Cells-PBSC Infusion) Up to 72 Months (6 Years) ]
    Neutrophil engraftment is defined as absolute neutrophil count (ANC) > 500/µl on two consecutive measurements on different days.

  12. Proportion of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Recipients Who Experience Primary or Secondary Graft Failure [ Time Frame: From Day of Transplant (Receipt of Peripheral Blood Stem Cells-PBSC Infusion) Up to Day 28 Post Transplant ]

    Graft failure can either be primary (graft never established) or secondary (loss of an established graft).

    Primary graft failure is the absence of adequate hematopoiesis by Day T28, defined as meeting all of the following conditions:

    • Bone marrow cellularity <5%,
    • Peripheral White Blood Cell Count (WBC) < 500/µl,
    • Peripheral Absolute Neutrophil Count (ANC) < 100/ µl, and
    • Platelets < 10,000/ µl.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participant(s) must meet all of the following criteria to be eligible for this study:

  1. Diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria
  2. (Kurtzke) Expanded Disability Status Scale (EDSS) ≥ 2.0 and ≤ 5.5 at the time of randomization (Day 0)
  3. T2 abnormalities on brain Magnetic Resonance Imaging (MRI) that fulfill the 2017 McDonald MRI criteria for dissemination in space

    --A detailed MRI report or MRI images must be available for review by the site neurology investigator.

  4. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of treatment failure in the 24 months prior to the screening visit (Visit -2). as described below:

    1. Each episode of treatment failure must occur following ≥ 3 months of treatment with an FDA-approved Disease-modifying Therapy (DMT) for relapsing forms of MS, or with rituximab, and
    2. At least one episode of treatment failure must occur with an oral agent or a monoclonal antibody, specifically: dimethyl fumarate (Tecfidera®), teriflunomide (Aubagio®), cladribine (Mavenclad®), daclizumab (Zinbryta®), siponimod (Mayzent®), fingolimod (Gilenya®), rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or alemtuzumab (Campath®, Lemtrada®), and
    3. At least one episode of treatment failure must have occurred within the 12 months prior to the screening visit (Visit -2), and
    4. At least one episode of treatment failure must be a clinical MS relapse (see item d.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical

    MS relapse or MRI evidence of disease activity (see item d.ii. below):

    i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee, and

    ii. MRI evidence of disease activity must include ≥ 2 unique active lesions on a brain or spinal cord MRI. A detailed MRI report or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following:

    • A gadolinium-enhancing lesion, or
    • A new non-enhancing T2 lesion compared to a reference scan obtained not more than 24 months prior to the screening visit (Visit -2).
  5. Candidacy for treatment with at least one of the following high efficacy DMTs: natalizumab, alemtuzumab, ocrelizumab, and/or rituximab.

    --Note: Rituximab and ocrelizumab are considered equivalent for candidacy.Candidacy for treatment for each DMT is defined as meeting all of the following:

    • No prior treatment failure with the candidate DMT, and
    • No contraindication to the candidate DMT, and
    • No treatment with the candidate DMT in the 12 months prior to screening.
  6. Insurance or public funding approval for MS treatment with at least one candidate DMT, and
  7. Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.

Exclusion Criteria:

Subject(s) who meet any of the following criteria will not be eligible for this study:

  1. Diagnosis of primary progressive Multiple Sclerosis (MS) according to the 2017 McDonald criteria
  2. History of neuromyelitis optica or anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibodies associated encephalomyelitis
  3. Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer
  4. Either of the following within one month prior to randomization (Day 0):

    1. Onset of acute MS relapse, or
    2. Treatment with intravenous methylprednisolone 1000 mg/day for 3 days or equivalent.
  5. Initiation of natalizumab, alemtuzumab, ocrelizumab, or rituximab between screening visit (Visit -2) and randomization (Day 0)
  6. Brain MRI or Cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML)
  7. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS)
  8. Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis
  9. History of sickle cell anemia or other hemoglobinopathy
  10. Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C

    -Note: Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.

  11. Presence or history of mild to severe cirrhosis
  12. Hepatic disease with the presence of either of the following:

    1. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin

      • 3.0 times the ULN in the presence of Gilbert's syndrome, or
    2. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN.
  13. Evidence of HIV infection
  14. Positive QuantiFERON - TB Gold or TB Gold Plus test results (e.g., blood test results that detect infection with Mycobacterium tuberculosis) Note: A Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON - TB Gold or TB Gold Plus test.
  15. Active viral, bacterial, endoparasitic, or opportunistic infections
  16. Active invasive fungal infection
  17. Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from an Infectious Disease specialist
  18. Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0)
  19. Presence or history of clinically significant cardiac disease including:

    1. Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature ventricular contractions
    2. Coronary artery disease with a documented diagnosis of either:

      • Chronic exertional angina, or
      • Signs or symptoms of congestive heart failure.
    3. Evidence of heart valve disease, including any of the following:

      • Moderate to severe valve stenosis or insufficiency,
      • Symptomatic mitral valve prolapse, or
      • Presence of prosthetic mitral or aortic valve.
  20. Left ventricular ejection fraction (LVEF) < 50%
  21. Impaired renal function defined as Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  22. Forced expiratory volume in one second (FEV1) <70% predicted (no bronchodilator)
  23. Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) < 70% predicted
  24. Poorly controlled diabetes mellitus, defined as HbA1c >8%
  25. History of malignancy, with the exception of adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix.

    -Note:Malignancies for which the participant is judged to be cured by therapy completed at least 5 years prior to randomization (Day 0) will be considered on an individual basis by the study adjudication committee.

  26. Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following:

    • systemic lupus erythematous
    • systemic sclerosis
    • rheumatoid arthritis
    • Sjögren's syndrome
    • polymyositis
    • dermatomyositis
    • mixed connective tissue disease
    • polymyalgia rheumatica
    • polychondritis
    • sarcoidosis
    • vasculitis syndromes, or
    • unspecified collagen vascular disease.
  27. Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer
  28. Prior history of AHSCT
  29. Prior history of solid organ transplantation
  30. Positive pregnancy test or breast-feeding
  31. Inability or unwillingness to use effective means of birth control
  32. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
  33. Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent
  34. History of hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins
  35. Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI with gadolinium administration
  36. Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage
  37. Presence or history of other neurological disorders, including but not limited to:

    • central nervous system (CNS) or spinal cord tumor
    • metabolic or infectious cause of myelopathy
    • genetically-inherited progressive CNS disorder
    • CNS sarcoidosis, or
    • systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments.
  38. Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality, or
  39. Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.

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): NCT04047628


Locations
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United States, California
Stanford Multiple Sclerosis Center Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Yamuna Joseph    650-529-5524    yamuna@stanford.edu   
Principal Investigator: Jeffrey Dunn, MD, FAAN         
United States, Colorado
Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Haley Steinert    303-724-4172    Haley.Steinert@ucdenver.edu   
Principal Investigator: John R. Corboy, MD         
United States, Massachusetts
Multiple Sclerosis Center, University of Massachusetts Memorial Medical Center Not yet recruiting
Worcester, Massachusetts, United States, 01605
Principal Investigator: Carolina Ionete, MD, PhD         
United States, Minnesota
University of Minnesota Multiple Sclerosis Center Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Susan Rolandelli    612-624-8431    rolan010@umn.edu   
Principal Investigator: Flavia Nelson, MD         
Neurology, Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Anton Mett    507-538-9812    mett.anton@mayo.edu   
Principal Investigator: B. Mark Keegan, MD,FRCPC         
United States, Missouri
John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Susan Sommer    314-362-2017    foxs@wustl.edu   
Principal Investigator: Gregory Wu, MD, PhD         
United States, New York
Baird Multiple Sclerosis (MS) Center, Kaleida Health Not yet recruiting
Buffalo, New York, United States, 14203
Contact: Kara Patrick    716-829-5037    kpatrick@buffalo.edu   
Principal Investigator: Bianca Weinstock-Guttman, PI         
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai Not yet recruiting
New York, New York, United States, 10029
Contact: Adam Aboelela    212-241-1598    adam.aboelela@mssm.edu   
Principal Investigator: Aaron Miller, MD         
Rochester Multiple Sclerosis Center, University of Rochester Not yet recruiting
Rochester, New York, United States, 14620
Contact: Patti Fenton, RN    585-275-6120      
Principal Investigator: Andrew D. Goodman, MD         
United States, North Carolina
Neurology, Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati (UC) Waddell Center for Multiple Sclerosis Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Molly Winters       molly.winters@uc.edu   
Principal Investigator: Aram Zabeti, MD         
Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Tim Hudec    216-445-1450    hudect@ccf.org   
Principal Investigator: Jeffrey A. Cohen, MD         
United States, Oregon
Multiple Sclerosis Center, Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Debbie Guess, RN    503-494-7651    griffide@ohsu.edu   
Principal Investigator: Yadav Vijayshree, MD,MCR,FANA,FAAN         
United States, Pennsylvania
Penn Comprehensive MS Center, Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tanyra Smith    215-662-4893    tanyra.smith@uphs.upenn.edu   
Principal Investigator: Amit Bar-Or, MD,FRCP,FAAN,FANA         
United States, Texas
University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Jan Cameron-Watts    214-645-0563    jan.CameronWatts@UTSouthwestern.edu   
Principal Investigator: Benjamin Greenberg, MD         
Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Tahari Griffin    713-798-6097    tgriffin@bcm.edu   
Principal Investigator: George J. Hutton, MD         
United States, Virginia
Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center Not yet recruiting
Richmond, Virginia, United States, 23219
Contact: Jeneane Henry, RN,BSN    804-828-7802    jeneane.henry@vcuhealth.org   
Principal Investigator: Unsong Oh, MD         
United States, Washington
Clinical Research Division, Fred Hutchinson Cancer Research Center Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Bernadette McLaughlin    206-667-4916    bmclaugh@fredhutch.org   
Principal Investigator: George E. Georges, MD         
Multiple Sclerosis Center, Swedish Neuroscience Institute Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Bernadette McLaughlin    206-667-4916    bmclaugh@fredhutch.org   
Principal Investigator: James D. Bowen, MD         
Multiple Sclerosis Center at Northwest Hospital Not yet recruiting
Seattle, Washington, United States, 98133
Contact: Elisa McGee       emcgee@uw.edu   
Principal Investigator: Annette Wundes, MD         
United Kingdom
Imperial College Healthcare NHS Trust Not yet recruiting
London, United Kingdom, W12 0NN
Principal Investigator: Paolo A. Muraro, MD,PhD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
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Study Chair: Jeffrey A. Cohen, MD Mellen Center for MS Treatment and Research, Cleveland Clinic
Study Chair: George E. Georges, MD Fred Hutchinson Cancer Research Center
Study Chair: Paolo A. Muraro, MD, PhD Department of Medicine, Imperial College London

Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04047628     History of Changes
Other Study ID Numbers: DAIT ITN077AI
UM1AI109565 ( U.S. NIH Grant/Contract )
NIAID CRMS ID#: 38573 ( Other Identifier: DAIT NIAID )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data access and additional relevant materials will be made available upon completion of the trial.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After completion of the trial, within 24 months status post database lock.
Access Criteria:

Registration is available for the Immunology Database and Analysis Portal (ImmPort) at: https://www.immport.org/registration and submit a rationale for the purpose of requesting study data access.

ImmPort is a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.

URL: https://www.immport.org/home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment-Resistant Relapsing Multiple Sclerosis (MS)
Autologous Hematopoietic Stem Cell Transplantation (AHSCT)
Autologous Peripheral Blood Stem Cells (PBMCs) Graft
Best Available Therapy (BAT)
Disease-Modifying Therapy (DMT)
BAT DMT
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Alemtuzumab
Natalizumab
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents
Antineoplastic Agents, Immunological