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Extracorporeal Photopheresis for Acute Graft Versus Host Disease

Primary Purpose

Graft Versus Host Disease, Cancer, Stem Cell Transplantation

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Extracorporeal Photopheresis
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring graft versus host disease, ECP, extracorporeal photopheresis, allogeneic transplantation

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Memorial HospitalRecruiting

Outcomes

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.
To estimate the response rate of ECP in steroid-refractory acute GVHD in children.

Secondary Outcome Measures

To evaluate the immunological mechanisms of ECP in acute GVHD.

Full Information

First Posted
September 10, 2005
Last Updated
October 7, 2010
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00179855
Brief Title
Extracorporeal Photopheresis for Acute Graft Versus Host Disease
Official Title
Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2003 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Cancer, Stem Cell Transplantation
Keywords
graft versus host disease, ECP, extracorporeal photopheresis, allogeneic transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Photopheresis
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
To estimate the response rate of ECP in steroid-refractory acute GVHD in children.
Time Frame
To end of study
Secondary Outcome Measure Information:
Title
To evaluate the immunological mechanisms of ECP in acute GVHD.
Time Frame
To end of study

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morris Kletzel, MD
Phone
773-880-4562
Email
djacobsohn@childrensmemorial.org
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Marshall
Phone
773-880-8153
Email
MeMarchall@childrensmemorial.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris Kletzel, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morris Kletzel, MD
Phone
773-880-4562
Email
MKletzel@childrensmemorial.org

12. IPD Sharing Statement

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Extracorporeal Photopheresis for Acute Graft Versus Host Disease

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