Extracorporeal Photopheresis for Acute Graft Versus Host Disease (NCT00179855) | Clinical Trial Compass
CompletedPhase 2/3
Extracorporeal Photopheresis for Acute Graft Versus Host Disease
United States10 participantsStarted 2003-07
Plain-language summary
The purpose of this research study is to evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Status-post allogeneic stem cell transplant (includes cord blood transplant, matched-unrelated-donor transplant and matched-related donor transplant) for any indication.
* HLA matching needs to be 4-6/6 by at least intermediate resolution for class I + II for cord blood and 5-6/6 for matched related or matched unrelated donors.
* Diagnosis of grade II-IV acute GVHD with histological confirmation of at least one organ (skin, gut, or liver) within the last 14 days. Grading of acute GVHD is per the standard Keystone criteria. Prior to enrollment, efforts should be made to rule out diagnoses that may mimic GVHD, such as drug rashes or GI infection. Patients that are being treated for acute GVHD and appear to be progressing to chronic GVHD are also eligible
* No improvement, or worsening, of acute GVHD after at least 4 days of IV methylprednisolone dosed at, at least 2.0mg/kg/day..
* Weight \>25.0kg.
* Adequate venous access.
Exclusion Criteria:
* Evidence of veno-occlusive disease.
* Intubated patient.
* Patient receiving dialysis.
* Age \> 30.
* Total bilirubin \>15mg/dL
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.
Timeframe: To end of study
2
To estimate the response rate of ECP in steroid-refractory acute GVHD in children.
Timeframe: To end of study
Trial details
NCT IDNCT00179855
SponsorAnn & Robert H Lurie Children's Hospital of Chicago