A clinical study in patients with moderate to severe graft-versus-host disease, patinets randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX.

Phase 1

• Conditions: Chronic graft-versus-host disease (cGvHD).; MedDRA version: 14.0Level: PTClassification code 10018651Term: Graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-022780-35-ES
• Lead Sponsor: THERAKOS, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-03
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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).
10. Hypersensitivity or allergy to both heparin and citrate products. (If hypersensitive or allergic to only one of
these two products, exclusion does not apply).
11. Inability to tolerate fluid changes associated with ECP (e.g., adequate renal, hepatic, pulmonary and cardiac
function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
12. Presense of aphakia or photosensitive disease (systemic lupus erythromatosus, porphyrias, albinism, etc.).
13. Women who are pregnant and/or lactating.
14. Participation in another clinical trial for treatment of cGvHD within 28 days prior to randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified