Status:
COMPLETED
Hematopoietic Stem Cell Transplant in Devic's Disease
Lead Sponsor:
Northwestern University
Conditions:
Devic's Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to examine whether treating Devic's disease patients with high dose cyclophosphamide together with rabbit antithymocyte globulin (rATG)/rituximab (drugs which reduce the functio...
Detailed Description
Neuromyelitis optica (NMO, Devic's disease) is an autoimmune, inflammatory, demyelinating central nervous system disorder in which a person's own immune system attacks the optic nerves and spinal cord...
Eligibility Criteria
Inclusion
- Age between 16-65, at the time of pretransplant evaluation
- An established diagnosis of Devic's disease (more than one acute attack)
- NMO- IgG aquaporin-4 autoantibody positive
Exclusion
- Paraplegia or quadriplegia and legal blindness (defined as visual acuity of 20/200 or less in the better eye with the best correction possible)
- Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy
- Prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix. Other malignancies for which the patient is judged to be cured, such as head and neck cancer, or breast cancer will be considered on an individual basis
- Positive pregnancy test
- Inability or unwillingness to pursue effective means of birth control. Effective birth control is defined as 1) refraining from all acts of vaginal intercourse (ABSTINENCE); 2) consistent use of birth control pills; 3) injectable birth control methods (Depo-provera, Norplant); 4) tubal sterilization or male partner who has undergone vasectomy; 5) placement of an intrauterine device (IUD); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam
- Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
- forced expiratory volume at one (FEV1) / forced vital capacity (FVC) \< 60% of predicted after bronchodilator therapy (if necessary)
- Diffusing capacity of lung for carbon monoxide (DLCO) \< 50% of predicted
- Resting left ventricular ejection fraction (LVEF) \< 50 %
- Serum creatinine \> 2.0 mg/dl
- Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins
- Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams
- Bilirubin \> 2.0 mg/dl
- Platelet count \< 100,000/ul or absolute neutrophil count (ANC) \< 1000/ul
- Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible
- Active infection except asymptomatic bacteriuria
- Inability to give informed consent
- HIV positive
- Transaminases \> 3x of normal limits, liver cirrhosis
Key Trial Info
Start Date :
October 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00787722
Start Date
October 10 2009
End Date
November 1 2018
Last Update
February 28 2020
Active Locations (1)
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1
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611