EUCTR2010-022780-35-ES
Active, not recruiting
Phase 1
A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEX TM for the Treatment of Patients with Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD).
ConditionsChronic graft-versus-host disease (cGvHD).MedDRA version: 14.0Level: PTClassification code 10018651Term: Graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsUVADEX TM
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic graft-versus-host disease (cGvHD).
- Sponsor
- THERAKOS, Inc.
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Are able to provide written informed consent.
- •2\. Meet NIH diagnostic criteria for initial onset of moderate to severe cGvHD with onset within 2 years of transplantation. Patients with prior acute cGvHD symptoms should be on a stable dose of \<0\.5 mg prednisone equivalent for at least 2 weeks prior to study entry.
- •3\. Age ? 18 years.
- •4\. Weight \> 40 kg.
- •5\. Platelet count \> 25,000/?L.
- •6\. Eastern Cooperative Oncology Group (ECOG) score of 0\-2\.
- •7\. Life expectancy of at least 3 months with no imminent relapse expected.
- •8\. 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.
- •9\. Women with childbearing potential must provide a negative pregnancy test within 10 days before study start.
- •10\. Patients must be able and willing to comply with all study procedures.
Exclusion Criteria
- •1\. Corticosteroid intolerance, based on previous clinical experience.2\. Previous treatment with \> 0\.5 mg/kg daily prednisone, or equivalent, for cGvHD for more than 72 hours prior
- •to randomization.
- •3\. Evidence of known infection with human immunodeficiency virus (HIV) or active Hepatitis B.
- •4\. Requires treatment with budesonide.
- •5\. Expected to receive donor lymphocyte infusion (DLI).
- •6\. Uncontrolled infection requiring treatment at study entry.
- •7\. Known definite bronchiolitis obliterans (biopsy proven).
- •8\. Patients who have received biologic therapy as part of treatment for acute cGvHD or conditioning regimen
- •which is expected to have a prolonged effect (e.g., alemtuzumab).
- •9\. Hypersensitivity or allergy to psoralen (methoxsalen).
Outcomes
Primary Outcomes
Not specified
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