Extracorporeal Photopheresis for Acute Graft Versus Host Disease

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00179855
• Other study ID #: BMT 0703
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 10, 2005
• Last updated: October 7, 2010
• Start date: July 2003
• Est. completion date: July 2012

Study information

• Verified date: October 2010
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Morris Kletzel, MD
• Phone: 773-880-4562
• Email: djacobsohn[@]childrensmemorial.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Graft Versus Host Disease
• Graft vs Host Disease
• Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To estimate the response rate of ECP in steroid-refractory acute GVHD in children.		To end of study	No
Secondary	To evaluate the immunological mechanisms of ECP in acute GVHD.		To end of study	No