Status:
WITHDRAWN
Autologous Transplant To End NMO Spectrum Disorder
Lead Sponsor:
Northwestern University
Conditions:
Neuromyelitis Optica
Devic's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed to treat your disease with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy to reset your immune system and to determine if your d...
Detailed Description
The autologous stem cell transplant used in this research study is an investigational procedure that uses cyclophosphamide (chemotherapy), rabbit antithymocyte globulin (rATG) (a protein that kills th...
Eligibility Criteria
Inclusion
- Age 18 - 65 years old at the time of pre-transplant evaluation
- An established diagnosis of NMOSD (with or without aquaporin 4 (AQP4)-IgG antibody)
Exclusion
- Under age of 18 or over age of 65
- Prisoners
- 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).
- Paraplegia or quadriplegia (must be able to use a walker if even for only a few feet)
- Extensive subcortical white matter lesions
- 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
- Myocardial infarction within the last 12 months. If longer than 12 months, must pass a dobutamine stress test and be cleared by cardiology.
- Active systemic lupus erythematous, Sjogren's, myasthenia gravis, or another autoimmune disease
- Sickle cell disease, sickle cell disease, or coagulopathy
- Prior history of malignancy that required any radiotherapy, chemotherapy, or biological therapy
- 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
- Women who are breastfeeding
- Untreated life-threatening cardiac arrhythmia on electrocardiogram (EKG) or 24-hour holter
- Left ventricular ejection fraction (LVEF) \<50%
- 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
- Serum creatinine \>2.0 mg/dl
- Liver cirrhosis, transaminases \>2x of normal limits, or bilirubin \>2.0 mg/dl unless due to Gilbert's disease
- Major hematological abnormalities such as platelet count \< 100,000/μl or absolute neutrophil count (ANC) \< 1000/μl
- Active infection except asymptomatic bacteriuria
- Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have magnetic resonance imaging (MRI) exams
- Known hypersensitivity to mouse, rabbit, or E. coli derived proteins
- Human immunodeficiency virus (HIV) positive
- Hepatitis B or C positive
- Use of natalizumab (Tysabri) within the previous six months
- Use of fingolimod (Gilenya) within the previous three months
- Use of dimethyl fumarate (Tecfidera) within the previous three months
- 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
- Use of alemtuzumab (Lemtrada/Campath) within previous 12 months
- Use of rituximab (Rituxan) or ocrelizumab (Ocrevus) within previous six months
- Prior treatment with mitoxantrone (Novantrone)
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03829566
Start Date
November 1 2019
End Date
November 28 2025
Last Update
November 20 2019
Active Locations (2)
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1
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Northwestern University
Chicago, Illinois, United States, 60611