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NCT02322190 · ClinicalTrials.gov registry record · Phase 2
Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT02322190: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02322190 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02322190, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD). They always get steroids as the first treatment, but this may not work. Those people where steroids are not enough may benefit from a treatment called extracorporeal photopheresis (ECP). ECP exposes white blood cells to ultraviolet light outside the body. Researchers want to study how certain markers in the blood predict the severity and outcome of acute GVHD and how ECP treatments work for people with acute GVHD. They will also study how these markers in the blood may help predict who should get ECP and its effects on the immune system. Objectives: \- To learn more about treatments for acute GVHD after allogeneic stem cell transplantation. Eligibility: \- Adults with acute GVHD enrolled in an National Cancer Institute (NCI) allogeneic transplantation protocol. Design: * Transplant physicians will confirm participant eligibility. * Participants will receive treatment with steroids for their acute GVHD as prescribed by their transplant physician. This will continue while they are enrolled on this study. * If steroids work in treating their acute GVHD, then every 28 days for 6 months, participants will have: * a physical exam. * blood tests. * If steroids do not work, participants will get additional treatments as prescribed by their transplant physician who may choose to use ECP as a part of this additional treatment. For ECP, blood is removed through an intravenous (IV) catheter. A machine separates the white blood cells from the other blood parts. Those cells are treated with methoxsalen and exposed to ultraviolet light. Then they are returned to the participant through their IV. * Participants who get ECP will over at least 6 months have: * veins researched. They may have a catheter placed in a larger vein in the chest or groin. * multiple blood tests. * multiple pregnancy tests (if needed). * multiple ECP procedures. * At the end of ECP treatment and
Interventions
- DRUG Methoxsalen
- PROCEDURE Extracorporeal Photopheresis (ECP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-12-20 |
| Est. Completion | 2019-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02322190
The ClinicalTrials.gov registry entry for NCT02322190 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methoxsalen is the first listed.
NCT02322190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02322190 about?
NCT02322190 is a clinical study titled "Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD". Background: \- Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD). They always get steroids as the first treatment, but this may not work. Those people where steroids are not enough may benefit from a treatment called extracorporeal photopheresis (ECP). ECP e...
What is the current status of trial NCT02322190?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2014-12-20. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT02322190?
The interventions under investigation include: Methoxsalen (DRUG), Extracorporeal Photopheresis (ECP) (PROCEDURE).
Who is sponsoring clinical trial NCT02322190?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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