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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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2019-11-30
2025-11-28
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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Hematopoietic Stem Cell Transplantation
Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, cyclophosphamide, mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.
Rituximab
Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
Cyclophosphamide
A medication used as chemotherapy and to suppress the immune system
Mesna
A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
rATG
A rabbit polyclonal antibody to lymphocytes
Methylprednisolone
A corticosteroid medication used to suppress the immune system and decrease inflammation
G-CSF
A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
IVIg
Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects
Autologous Stem Cells
Infusion of patient's own stem cells
Interventions
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Rituximab
Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
Cyclophosphamide
A medication used as chemotherapy and to suppress the immune system
Mesna
A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
rATG
A rabbit polyclonal antibody to lymphocytes
Methylprednisolone
A corticosteroid medication used to suppress the immune system and decrease inflammation
G-CSF
A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
IVIg
Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects
Autologous Stem Cells
Infusion of patient's own stem cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. An established diagnosis of NMOSD (with or without aquaporin 4 (AQP4)-IgG antibody)
Exclusion Criteria
2. Prisoners
3. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible, or any adult who is unable to consent (for adults cognitively impaired due to disease, consent may be obtained from the closest living relative).
4. Paraplegia or quadriplegia (must be able to use a walker if even for only a few feet)
5. Extensive subcortical white matter lesions
6. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment
7. Myocardial infarction within the last 12 months. If longer than 12 months, must pass a dobutamine stress test and be cleared by cardiology.
8. Active systemic lupus erythematous, Sjogren's, myasthenia gravis, or another autoimmune disease
9. Sickle cell disease, sickle cell disease, or coagulopathy
10. Prior history of malignancy that required any radiotherapy, chemotherapy, or biological therapy
11. Positive pregnancy test, inability or unable to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
12. Women who are breastfeeding
13. Untreated life-threatening cardiac arrhythmia on electrocardiogram (EKG) or 24-hour holter
14. Left ventricular ejection fraction (LVEF) \<50%
15. Tiffeneau-Pinelli index (FEV1/FVC) \<70% of predicted after bronchodilator therapy (if necessary), or diffusing capacity of lung for carbon monoxide (DLCO) hemoglobin corrected \<70 % predicted
16. Serum creatinine \>2.0 mg/dl
17. Liver cirrhosis, transaminases \>2x of normal limits, or bilirubin \>2.0 mg/dl unless due to Gilbert's disease
18. Major hematological abnormalities such as platelet count \< 100,000/μl or absolute neutrophil count (ANC) \< 1000/μl
19. Active infection except asymptomatic bacteriuria
20. Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have magnetic resonance imaging (MRI) exams
21. Known hypersensitivity to mouse, rabbit, or E. coli derived proteins
22. Human immunodeficiency virus (HIV) positive
23. Hepatitis B or C positive
24. Use of natalizumab (Tysabri) within the previous six months
25. Use of fingolimod (Gilenya) within the previous three months
26. Use of dimethyl fumarate (Tecfidera) within the previous three months
27. Use of teriflunomide (Aubagio) unless cleared from the body (plasma concentration \<0.02mcg/ml) following elimination from the body with cholestyramine 8g three times a day for 11 days
28. Use of alemtuzumab (Lemtrada/Campath) within previous 12 months
29. Use of rituximab (Rituxan) or ocrelizumab (Ocrevus) within previous six months
30. Prior treatment with mitoxantrone (Novantrone)
18 Years
65 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Richard Burt, MD
Professor
Principal Investigators
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Richard Burt, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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DIAD.ATTEND.2018
Identifier Type: -
Identifier Source: org_study_id
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