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


Phase 2/Phase 3
N/A
30 Years
Open (Enrolling)
Both
Graft Versus Host Disease, Cancer, Stem Cell Transplantation

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.

Outcome Time Frame:

To end of study

Safety Issue:

Yes

Principal Investigator

Morris Kletzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

BMT 0703

NCT ID:

NCT00179855

Start Date:

July 2003

Completion Date:

July 2012

Related Keywords:

  • Graft Versus Host Disease
  • Cancer
  • Stem Cell Transplantation
  • graft versus host disease
  • ECP
  • extracorporeal photopheresis
  • allogeneic transplantation
  • Graft vs Host Disease

Name

Location

Children's Memorial HospitalChicago, Illinois  60614