Extracorporeal Photopheresis for Acute Graft Versus Host Disease

Phase 2

Completed

• Conditions: Graft Versus Host Disease; Cancer; Stem Cell Transplantation

• Registration Number: NCT00179855
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.	To end of study
To estimate the response rate of ECP in steroid-refractory acute GVHD in children.	To end of study

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunological mechanisms of ECP in acute GVHD.	To end of study

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States