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.
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.
Study Type
OBSERVATIONAL
Enrollment
19
Ancillary studies
Ancillary studies
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
6-month freedom from treatment failure, defined as a patient being alive, without relapse of underlying disease, and without the addition of new systemic therapy for the treatment of aGVHD, within 6 months of starting second line therapy
Rates of 6 m FFTF will be estimated by subtracting rates of total failures from 100%.
Time frame: 6 months
Cumulative incidence estimates of relapse
Cox regression models will be used to identify risk factors for failure.
Time frame: Up to 2 years
Cumulative incidence estimates of non-relapse mortality
Cox regression models will be used to identify risk factors for failure.
Time frame: Up to 2 years
Treatment change as causes of failure during second line treatment
Cox regression models will be used to identify risk factors for failure.
Time frame: Up to 2 years
Health care burden in patients receiving second line therapy for acute GVHD
The incremental budget spend between the patients receiving treatment with ECP and patients receiving other modalities will be measured and economic methods will be used to calculate an incremental cost effectiveness ratio for relevant clinical end points. Health economic data relating to hospitalizations (length of stay in myelosuppressive unit, high-dependency unit \[step-down unit\], intensive care unit), high cost drugs, total parenteral nutrition and surgical procedures will also be collected allowing comparisons to be made between patients treated with ECP and other treatment options.
Time frame: Up to 6 months
Quality of life measured using FACT-BMT
Time frame: Up to 6 months
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Medical University Vienna
Vienna, Austria
Klinikum der Universität Regensburg
Regensburg, Germany
Nottingham City Hospital
Nottingham, United Kingdom