An observational study in Graft Versus Host Disease, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-17.
Sponsored by Vanderbilt-Ingram Cancer Center · Observational
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.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 19 is below the median of 94 across 102 observational studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study targets patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Patients can be enrolled by all participating locations.
Corticosteroid refractory or corticosteroid dependent aGVHD
Exclusion Criteria:
Study data are collected and managed using REDCap tools at baseline and on days 5, 28, and 56.
Other: medical chart review · Other: quality-of-life assessment
Ancillary studies
Also known as: chart review
Ancillary studies
Also known as: quality of life assessment
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
This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center