Vanderbilt Clinical Trials

• Enrollment on study is within 5 days (including weekends) of starting second-line therapy - aGVHD grade 2 or higher at time of enrollment; patients with late acute and recurrent aGVHD are permitted - Donor lymphocyte induced aGVHD is permitted ONLY IF donor lymphocyte infusion given for mixed chimerism and not for progression of disease and meeting all other inclusion and

will be eligible - Corticosteroid refractory or corticosteroid dependent aGVHD - Corticosteroid refractory aGVHD is defined as worsening of aGVHD after 3 days of systemic corticosteroids (minimum dose of 1 mg/kg), or no improvement after 7 days of systemic corticosteroids (minimum dose of 1 mg/kg) - Corticosteroid dependent aGVHD is defined as recurrence of aGVHD (grade 2 or higher) during corticosteroid taper and prior to reaching 50% of initial starting dose of corticosteroids - Informed consent form Exclusion Criteria: - Has received corticosteroids at 2 mg/kg or higher for 3 weeks or longer as part of first-line therapy for aGVHD - Has received systemic therapy other than corticosteroids for treatment of aGVHD as part of first-line therapy for acute GVHD; simultaneous uses of topical or enteric corticosteroids or psoralen plus ultraviolet A (PUVA) for first-line are permitted - aGVHD after second hematopoietic cell transplantation (HCT) is excluded - Karnofsky performance status =< 50% - Requiring mechanical ventilation or renal replacement therapy at the time of enrollment - Histologic or flow-cytometric evidence of relapse or progression of underlying disease; molecular or cytogenetic presence of disease is permitted; mixed chimerism is permitted - Current or prior diagnosis of chronic GVHD (classic or overlap) as defined by National Institutes of Health (NIH) consensus criteria - Donor lymphocyte infusion (DLI)-induced aGVHD when DLI was given for progression of the underlying disease