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Photopheresis + Aldesleukin for Chronic Graft-Versus-Host Disease
Study Summary
This trial is testing a new treatment for chronic graft-versus-host disease that involves removing and treating a patient's blood with ultraviolet light and drugs, then returning it to the patient. The goal is to increase T-reg cells in patients with cGVHD.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You had a donor lymphocyte infusion within the last 100 days before joining the study.You have taken any new medication that weakens your immune system in the last 4 weeks before joining the study.You should not have any serious illness or active infection. If you are currently taking a high dose of prednisone, you will not be able to participate.Your platelet count is higher than 50,000 per cubic millimeter.You have a history of specific blood disorders that involve clotting and damage to red blood cells.You currently have a recurring cancer.If you have HIV and are taking medicine for it, you cannot participate.You have had allergic reactions to drugs similar to IL-2.Your total bilirubin level is less than 2.0 mg/dl, unless you have Gilbert's syndrome.You cannot have any other cancer that is currently growing, except for certain types of skin cancer.You have received a specific type of stem cell transplant, except for certain alternative donor transplants.Patients with ongoing chronic GVHD that needs medication are allowed to participate.You still have signs and symptoms of cGVHD even after using prednisone for at least 4 weeks without complete improvement.You are generally able to perform daily activities and take care of yourself.You are expected to live for more than 3 months.Your liver enzymes (AST and ALT) should not be more than twice the upper limit of normal, unless your liver problems are related to a specific condition called cGVHD.If your liver function tests are abnormal due to a specific medical condition called cGVHD and your doctor confirms it, you may still be allowed to participate.Your kidney function is within the normal range or your creatinine clearance is higher than 60 mL/min/1.73 m^2 if your creatinine levels are higher than normal.Your white blood cell count is higher than 1000 per cubic millimeter.You have chronic graft-versus-host disease that hasn't responded to steroids and have tried multiple other treatments. You can have had a treatment called ECP before, but not IL-2.You have severe chest pain or heart failure symptoms that are not under control.
- Group 1: Supportive care (aldesleukin and ECP)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA cleared Extracorporeal Photopheresis for use?
"Extracorporeal Photopheresis has only been proven to be safe in Phase 2 trials, so it scored a 2."
Are we looking for more participants in this experiment?
"This particular clinical trial is not looking for new patients as of February 17th, 2022. The most recent update on the study was published 236 days ago on January 18th, 2017. Although this research project isn't currently recruiting, there are other opportunities available with ongoing trials."
Are there similar procedures to Extracorporeal Photopheresis?
"As of right now, there are 62 clinical trials underway for Extracorporeal Photopheresis. Of these active studies, 5 have progressed to Phase 3. Even though the majority of trials for this treatment are based in Boston, Massachusetts, 400 different locations across the country are running tests."
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