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: 17.0Level: 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-DE
• Lead Sponsor: THERAKOS, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-09
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

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

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.
11. Women with childbearing potential must provide a negative pregnancy test within 10 days before study start.
12. 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.
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.
8b. Patients who are receiving alemtuzumab, antithymocyte globulin (ATG) or other similar pharmacologically long-acting agents used for treatment of acute or chronic GvHD or administered during the conditioning regimen <90 days prior to randomization.
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., inadequate renal, hepatic, pulmonary and cardiac function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
12. Presence of aphakia or photosensitive disease (systemic lupus erythromatosus, porphyrias, albinism, etc.). If the eye with aphakia has no vision capabilities then the patient may be included in the study.
13. Women who are pregnant and/or lactating.
14. Have used any investigational drug/treatment within the previous 28 days prior to randomization.

Study & Design

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