Extracorporeal Photopheresis for Acute Graft Versus Host Disease
Information source: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft Versus Host Disease; Cancer; Stem Cell Transplantation
Intervention: Extracorporeal Photopheresis (Procedure)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Ann & Robert H Lurie Children's Hospital of Chicago Official(s) and/or principal investigator(s): Morris Kletzel, MD, Principal Investigator, Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
Overall contact: Morris Kletzel, MD, Phone: 773-880-4562, Email: djacobsohn@childrensmemorial.org
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.
Clinical Details
Official title: Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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 estimate the response rate of ECP in steroid-refractory acute GVHD in children.
Secondary outcome: To evaluate the immunological mechanisms of ECP in acute GVHD.
Eligibility
Minimum age: N/A.
Maximum age: 30 Years.
Gender(s): Both.
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
Locations and Contacts
Morris Kletzel, MD, Phone: 773-880-4562, Email: djacobsohn@childrensmemorial.org
Children's Memorial Hospital, Chicago, Illinois 60614, United States; Recruiting Morris Kletzel, MD, Phone: 773-880-4562, Email: MKletzel@childrensmemorial.org
Additional Information
Starting date: July 2003
Last updated: October 7, 2010
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