Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis

Stopped early · Not applicable

Conditions studied: Graft Versus Host Disease (GVHD)

In brief

This clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Studying samples of blood from patients with GVHD may help doctors identify and learn more about biomarkers related to GVHD.

Key facts

Study ID

NCT01324908

Run by

Vanderbilt-Ingram Cancer Center

People needed

85

Starts

2011-07-01

Expected to finish

2020-11-16

Last updated by the study team

2021-01-14

Who can join

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

You may qualify if…

• Patients with any NIH subtype of chronic GVHD that is being treated with ECP
• Karnofsky Performance Scale (KPS) > 60% at time of study enrollment
• Life expectancy > 3 months
• Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment
• If patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
• No use of an investigational agent within 2 weeks of starting ECP
• No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
• No evidence of relapse or progression of underlying disease (molecular evidence of relapse/progression or mixed chimerism is permitted)
• Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

You may not qualify if…

• Female patients who are breastfeeding or pregnant
• Patients known to be human immunodeficiency virus (HIV) positive
• Bronchiolitis obliterans as the sole indication of ECP
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• Mechanical ventilation, renal replacement therapy, admitted in intensive care until at time of enrollment
• Stage 4 gastrointestinal GVHD as per Seattle-Glucksberg criteria

Where it is running

• Emory University — Atlanta, Georgia, United States
• Dana Farber Cancer Center — Boston, Massachusetts, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Virginia Commonwealth University, Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.