Extracorporeal Photopheresis for Acute Graft Versus Host Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179855
First received: September 10, 2005
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Graft Versus Host Disease
Cancer
Stem Cell Transplantation
Procedure: Extracorporeal Photopheresis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To estimate the response rate of ECP in steroid-refractory acute GVHD in children. [ Time Frame: To end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the immunological mechanisms of ECP in acute GVHD. [ Time Frame: To end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2003
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Extracorporeal Photopheresis

    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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179855

Contacts
Contact: Morris Kletzel, MD 773-880-4562 djacobsohn@childrensmemorial.org
Contact: Meredith Marshall 773-880-8153 MeMarchall@childrensmemorial.org

Locations
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Morris Kletzel, MD    773-880-4562    MKletzel@childrensmemorial.org   
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Morris Kletzel, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Morris Kletzel, MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179855     History of Changes
Other Study ID Numbers: BMT 0703
Study First Received: September 10, 2005
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
graft versus host disease
ECP
extracorporeal photopheresis
allogeneic transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014