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

Stopped early

Conditions studied: Graft Versus Host Disease

In brief

This research trial studies medical chart review in determining outcomes of second-line therapy in patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Gathering information about second-line therapy in patients with acute graft-versus-host disease may help doctors learn more about the disease and find better treatment.

Key facts

Study ID

NCT02151539

Run by

Vanderbilt-Ingram Cancer Center

People needed

19

Starts

2014-08-29

Expected to finish

2018-10-11

Last updated by the study team

2019-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt-Ingram Cancer Center (VICC) — Nashville, Tennessee, United States
• Medical University Vienna — Vienna, Austria
• Klinikum der Universität Regensburg — Regensburg, Germany
• Nottingham City Hospital — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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