A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEX™ for the Treatment of Patients with Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

THERAKOS, Inc.0 sites60 target enrollmentMay 12, 2011

DrugsUVADEX™

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: THERAKOS, Inc.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 12, 2011

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

THERAKOS, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Are able to provide written informed consent.
•2\. Patients with new onset moderate or severe cGvHD per NIH Consensus Criteria (for staging and severity) definition as assessed by the NIH Consensus Criteria Clinical Assessment (NIH Clinical Assessment Forms and instructions are provided in Study Reference Manual) with onset within 3 years of transplantation.
•3\. Willingness to start treatment with 1\.0 mg/kg prednisone, or equivalent, at baseline.
•4\. Patients with prior acute GvHD symptoms should be on a stable dose of \=0\.5 mg/kg daily prednisone. or equivalent, for at least 2 weeks prior to study entry. Prior ECP for acute GvHD is permitted in the study.
•5\. Age \= 18 years.
•6\. Weight \> 40 kg.
•7\. Platelet count \> 25,000/µL (including platelet support).
•8\. Eastern Cooperative Oncology Group (ECOG) score of 0\-2\.
•9\. Life expectancy of at least 3 months with no imminent relapse expected.
•10\. Women of childbearing potential and all men must be using adequate birth control measures (e.g., abstinence, oral contraceptive, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the study.

Exclusion Criteria

•1\. Corticosteroid intolerance, based on previous clinical experience.
•2a. Previous treatment with \> 2\.0 mg/kg daily prednisone, or equivalent, during the 7 days prior to the baseline visit.
•2b. Previous treatment with systemic steroids for moderate to severe chronic GvHD for more than 7 days prior to the baseline visit.
•2c. Previous treatment for mild cGvHD with \>0\.5 mg/kg of prednisone or equivalent during the 2 weeks prior to screening.
•3\. Evidence of known infection with human immunodeficiency virus (HIV) or active (not including latent) Hepatitis B (laboratory testing is not required if virus status is already known).
•4\. Requires treatment with budesonide and/or similar low absorption oral steroids and steroid enema preparations. Patients who have discontinued these medications at screening will be eligible for the study.
•5\. Expected to receive donor lymphocyte infusion (DLI). Patients who have received DLI in the past are still eligible for the study.
•6\. Uncontrolled infection requiring treatment at study entry.
•7\. Known definite bronchiolitis obliterans (biopsy proven).
•8a. Patients who are receiving myciphenolate mofetil (MMF), tyrosine kinase inhibitors (TKIs), such as imatinib, sunitinib and dasatinib, anti\-tumor necrosis factor (TNF)agents, sirolimus and bortezomib or patients who are receiving PUVA therapy. Patients who have discontinued these medications or PUVA at screening will be eligible for the study. If MMF needs to be tapered, the taper should start at screening and be completed (i.e., medication discontinued) by Day 7 post baseline.