Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)

PRIMARY OBJECTIVES:

I. To determine 6-month freedom from treatment failure for second-line therapy for acute
graft versus host disease (aGVHD).

II. To show that extracorporeal photopheresis (ECP) is associated with a superior 6 month (m)
freedom from treatment failure (FFTF) as compared to other treatment modalities for second
line therapy for aGVHD.

III. To describe health care burden in patients receiving second line therapy for acute GVHD.

IV. Quality of life measurement using Functional Assessment of Cancer Therapy-Bone Marrow
Transplant (FACT-BMT) in patients receiving second line therapy for aGVHD.

OUTLINE:

Study data are collected and managed using Research Electronic Data Capture (REDCap) tools at
baseline and on days 5, 28, and 56.

After completion of study, patients are followed up at 6 months, and 1 and 2 years.

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