Extracorporeal Photopheresis for Acute Graft Versus Host Disease

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00179855
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 108
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.
• Study Start Date: Jul 1, 2003
• Anticipated Primary Completion Date: Jul 1, 2012
• Anticipated Study Completion Date: Jul 1, 2012

Outcome Measures

Primary Outcome Measures

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. [To end of study]

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

Secondary Outcome Measures

1. To evaluate the immunological mechanisms of ECP in acute GVHD. [To end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Memorial Hospital	Chicago	Illinois	United States	60614

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00179855
• Other Study ID Numbers: BMT 0703
• First Posted: Sep 16, 2005
• Last Update Posted: Oct 11, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: graft versus host disease; ECP; extracorporeal photopheresis; allogeneic transplantation
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Oct 11, 2010