Clinical Trials

Inclusion Criteria:

• 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 exclusion criteria 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