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NCT03829566WithdrawnPhase 2/3

Autologous Transplant To End NMO Spectrum Disorder

Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Source: ClinicalTrials.gov · Last updated 20 Nov 2019

Reason given: Discontinued by Investigator

Brief summary (registry, in English)

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 disease will go into long-term remission.

Status (registry)
Withdrawn
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
0 (actual)
First submitted
1 Feb 2019
Start date
Nov 2019
Primary completion date
Jan 2025
Lead sponsor
Northwestern University
NCT number
NCT03829566

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 alemtuzumab (Lemtrada/Campath) within previous 12 months
  • Use of rituximab (Rituxan) or ocrelizumab (Ocrevus) within previous six months
  • Prior treatment with mitoxantrone (Novantrone)

Other illness

  • 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).
  • 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
  • Untreated life-threatening cardiac arrhythmia on electrocardiogram (EKG) or 24-hour holter
  • Active infection except asymptomatic bacteriuria
  • Known hypersensitivity to mouse, rabbit, or E. coli derived proteins
  • Human immunodeficiency virus (HIV) positive
  • Hepatitis B or C positive

Lab values

  • 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

Age

  • Under age of 18 or over age of 65

Other

  • Prisoners
  • Paraplegia or quadriplegia (must be able to use a walker if even for only a few feet)
  • Extensive subcortical white matter lesions
  • Women who are breastfeeding
  • Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have magnetic resonance imaging (MRI) exams
  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Northwestern University Feinberg School of MedicineChicagoUnited StatesUnknown status
Northwestern UniversityChicagoUnited StatesUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.