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The purpose of this study is to test if a new drug named visilizumab is able to decrease the severity of graft-versus-host disease in patients treated with a mismatched donor. In this study we will use visilizumab in combination with tacrolimus and methotrexate that is the "study treatment".
This protocol is a two stage, controlled, phase II study, to assess safety and compare the grade of acute graft-versus-host disease (GVHD) with visilizumab or thymoglobulin (ATG) in combination with tacrolimus + methotrexate in patients at high risk of GVHD after transplant from unrelated donors mismatched for 1-2 alleles of any type at HLA A, B, C and DRB1.
The study design includes two stages. The first stage of the trial will enroll 15 patients on a single arm to be treated with "study treatment" (visilizumab, tacrolimus and methotrexate) to assess for treatment safety and exclude intolerable GVHD. The second stage of the trial includes a random control group of patients treated with the current "standard treatment" (ATG, tacrolimus, and methotrexate) or "study treatment". The purpose of this comparison is to determine if the "study treatment" visilizumab causes less severe side effects and if it is more potent in reducing graft-versus-host disease symptoms than the "standard treatment".
In addition, immunological studies will be conducted to test the pharmacokinetics, immunogenicity, and pharmacodynamics of visilizumab or ATG administered for GVHD prophylaxis after hematopoietic cell transplantation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Graft Versus Host Disease
Visilizumab, Tacrolimus, Methotrexate, Antithymocyte globulin (ATG), Tacrolimus, Methotrexate
H. Lee Moffitt Cancer Center & Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Published on BioPortfolio: 2014-08-27T03:28:54-0400
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A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-
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A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.
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