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Clinical Trial VICCBMT1129

Title

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

Principal Investigator(s)

Madan Jagasia

Details

  • Protocol No. VICCBMT1129
  • Open Date: 11/17/2011
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the efficacy of ECP as determined by the incremental improvement in cGvHD according to National Institutes of Health (NIH) Consensus Response Criteria versus a control population.
  • Disease Sites: Supportive Care; Lymphoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics; Therapy (NOS)
  • Drugs: UVADEX (methoxsalen)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01380535
  • Secondary Protocol No: 10-005

Description

Subjects are being asked to take part in this research study because they have moderate to severe chronic Graft-versus-Host Disease (cGvHD). This study will provide information about a possible new treatment to treat this condition. This clinical research study is being sponsored by THERAKOS, Inc. The purpose of this study is to see whether or not a new treatment called extracorporeal photopheresis (ECP) therapy works (makes you feel better) and whether it is safe to use in patients with moderate to severe cGvHD. The basic idea of this therapy involves the collection of blood from the subject and the treatment of that blood, first with a medication, then with ultraviolet light, after which the blood is returned to the subject. This study compares ECP therapy in addition to standard drug treatment against standard drug treatment alone. Standard drug treatment is a treatment with the most common approved medicines that a doctor would give to patients for the treatment of their condition. The standard drug treatment consists of corticosteroids (drugs that reduce inflammation) and an immunosuppressant (drugs that suppress the response of your immune system) called cyclosporine. The kind of treatment that patients will be given will be decided randomly, like tossing a coin. About half of the subjects will receive standard drug treatment plus ECP and the other half, standard drug treatment alone, for the entire study. Therefore, subjects should take part in this study only if they are willing to receive either treatment. About 60 patients with moderate to severe cGvHD will take part at about 40 centers, which are located in about 7 countries (Austria, France, Germany, Italy, Spain, United Kingdom, United States of America, and others).

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Have new onset of moderate or severe cGvHD as assessed by the NIH Consensus Criteria Clinical Assessment (staging and severity) with onset within 2 years of transplantation (Patients with prior acute GvHD 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 patients with acute GvHD is permitted in the study);willing to start 1.0mg/kg prednisone: Be using adequate birth control; If a woman, must have negative pregnancy test result at screening: Be able and willing to comply with all study procedures including providing informed consent
Exclusion Criteria:
• Be intolerant to corticosteroids; Received treatment with >2.0 mg daily prednisone, or equivalent, for cGvHD for more than 7 days prior to baseline visit; received treatment with prednisone for mild cGVHD with >.5mg/kg for > 14 days, Have evidence of known infection with human immunodeficiency virus (HIV), active Hepatitis B infection, or have uncontrolled infection requiring treatment at the time of study entry; Requires treatment with budesonide and similar low absorption oral steroids and steroid enema preparations; Receiving treatment with mycophenolate mofetil (MMF),PUVA, tyrosine kinase inhibitors, anti-tumor necrosis factor (TNF) agents, sirolimus, and bortezomib; Receiving treatment with alemtuzumab, antithymocyte globulin (ATG) or other similar long-acting agents used for treatment of acute or chronic GvHD or administered during the conditioning regimen <90 days prior to randomization