T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)

Exclusion Criteria

• •1. Patients who have been diagnosed with overlap syndrome, that is, with any concurrent features of cGVHD.
• •2. Patients requiring any of the following: mechanical ventilation, vasopressor support, or hemodialysis.
• •3. Patients who have received any systemic treatment, besides steroids, as upfront treatment of aGVHD OR as treatment for SR-aGVHD.
• •4. Patients who have severe hypoalbuminemia, with an albumin of less than or equal to 1 g/dl.
• •5. Patients who have a CK level of greater than 5 times the upper limit of normal.
• •6. Patients with uncontrolled infections. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
• •7. Patients with evidence of relapsed, progressing or persistent malignancy.
• •8. Patients with evidence of minimal residual disease requiring withdrawal of systemic immune suppression
• •9. Patients with known hypersensitivity to any of the components murine monoclonal antibodies (mAb) or Recombinant Ricin Toxin A-chain (RTA).
• •10. Patients who have received more than one allo-HSCT.
• •11. Patients with known human immunodeficiency virus infection.
• •12. Female patients who are pregnant, breast feeding, or, if sexually active and of childbearing potential, unwilling to use effective birth control from start of treatment until 30 days after the last infusion of T-Guard.
• •13. Male patients who are, if sexually active and with a female partner of childbearing potential, unwilling to use effective birth control from start of treatment until 65 days after the last infusion of T-Guard.
• •14. Patients with any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data.
• •15. Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.