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Does the patient have evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology?
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Has the patient received a previous hematopoietic stem cell transplant (HCT)?
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How many times did the patient experience a new onset of seizure during this assessment period?
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Date of first occurrence of any significant cerebrovascular event during this assessment period
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Has the patient received a prior solid organ transplant?
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Has the patient participated in another clinical trial in which the patient received an investigational or off-label use of a drug or device within 3 months of enrollment?
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Is the patient pregnant or breastfeeding?
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Does the patient have a clinically significant, uncontrolled autoimmune disease requiring active medical management (immunosuppressive therapy or chemotherapy), which, in the judgment of the local Principal Investigator, indicates that the patient could not tolerate transplantation?
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Is the patient a female of childbearing potential (FCBP) (all females > 10 years of age, unless post-menopausal for a minimum of 1 year before the time of consent or surgically sterilized)?
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Did the patient experience renal function compromise (proteinuria or increased creatinine grades greater than or equal to 2 per CTCAE version 4.0) during this assessment period?
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Does the patient agree either (1) to practice 2 effective methods of contraception at the same time, or (2) to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject, from the time of signing of informed consent through 12 months post-transplant?
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Did the patient experience a new onset of proteinuria during this assessment period?
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Does the patient (even if surgically sterilized) agree to practice effective barrier contraception, or agree to practice true abstinence from the time of signing informed consent through 12 months post-transplant?
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Date of new onset of proteinuria
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Is there a presence of anti-donor specific HLA antibodies?
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Did the patient experience a new onset of increased creatinine (grades greater than or equal to 2 per CTCAE version 4.0) during this assessment?
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Date solid phase immunoassay performed to determine HLA antibody presence and specificity
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Was MFI >1000 for donor specific antibody to HLA-A, -B, DRB1 and/or MFI >2000 for HLA-C, DQB1 and DPB1?
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Date of Protocol Chair and/or Protocol Officer approval
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Is the donor willing to donate bone marrow?