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NCT Number: NCT00179855

Extracorporeal Photopheresis for Acute Graft Versus Host Disease

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.

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Key information

Conditions

Graft Versus Host Disease Cancer Graft vs Host Disease Immune System Diseases Neoplasms Stem Cell Transplantation

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Photopheresis

Procedure

ECP will be performed using the UVAR® XTS™ photopheresis system (Therakos). Whole blood is drawn and separated by centrifuge to collect the buffy coat (lymphocyte solution). Methoxsalen (8-MOP) is added to the blood, and the final solution of cells is passed as a film, 1mm thick, through a disposable plastic device, exposed to a UVA light source (2J/cm2/cell) and then returned to the patient.

ECP will be performed weekly on 2 consecutive days for 4 weeks. After 4 weeks the interval will be prolonged to every 2 weeks and ECP will be stopped after maximal response has been maintained for 2 weeks. The actual study finishes at d56 but ECP may be continued beyond that (off-study) at the discretion of the physician.

Primary outcomes

  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.

    Time frame: To end of study

  2. To estimate the response rate of ECP in steroid-refractory acute GVHD in children.

    Time frame: To end of study

Secondary outcomes

  1. To evaluate the immunological mechanisms of ECP in acute GVHD.

    Time frame: To end of study

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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