Clinical trial · Interventional
Extracorporeal Photopheresis for Acute Graft Versus Host Disease
Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.
NCT00179855CI-TRIAL-00085857completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extracorporeal Photopheresis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- measure
- To estimate the response rate of ECP in steroid-refractory acute GVHD in children.
- timeFrame
- To end of study
Secondary outcomes (1)
- measure
- To evaluate the immunological mechanisms of ECP in acute GVHD.
- timeFrame
- To end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.