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Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

2014-08-27 03:28:54 | BioPortfolio

Summary

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".

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Graft Versus Host Disease

Intervention

Visilizumab, Tacrolimus, Methotrexate, Antithymocyte globulin (ATG), Tacrolimus, Methotrexate

Location

H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
United States
33612

Status

Recruiting

Source

H. Lee Moffitt Cancer Center and Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:28:54-0400

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Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

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Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation

To compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease.

PubMed Articles [1479 Associated PubMed Articles listed on BioPortfolio]

Tocilizumab, tacrolimus and methotrexate for the prevention of acute graft versus host disease: low incidence of lower gastrointestinal tract disease.

We conducted a phase 2 study in which patients undergoing allogeneic hematopoietic stem cell transplantation received Tocilizumab in addition to standard immune suppression with tacrolimus and methotr...

Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression: Erratum.

Determination of Tacrolimus Concentration and Protein Expression of P-Glycoprotein in Single Human Renal Core Biopsies.

Tacrolimus is currently the cornerstone of immunosuppressive protocols for renal transplant recipients. Despite therapeutic whole blood monitoring, tacrolimus is associated with nephrotoxicity and it ...

Mood changes with methotrexate therapy for dermatologic disease.

Neurotoxicity and cognitive effects of low-dose methotrexate for rheumatologic disease have often been described, but the neuropsychiatric effects of low-dose methotrexate for cutaneous disease have b...

Dose optimisation of tacrolimus with therapeutic drug monitoring and CYP3A5 polymorphism in myasthenia gravis patients.

Tacrolimus was beneficial for treatment of myasthenia gravis (MG). And it has a narrow therapeutic range, therefore, therapeutic drug monitoring (TDM) is essential for tacrolimus to optimize dosage an...

Medical and Biotech [MESH] Definitions

A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.

A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-

A serine threonine kinase that controls a wide range of growth-related cellular processes. The protein is referred to as the target of RAPAMYCIN due to the discovery that TACROLIMUS (commonly known as rapamycin) forms an inhibitory complex with TACROLIMUS BINDING PROTEIN 1A that blocks the action of its enzymatic activity.

An antineoplastic antimetabolite with immunosuppressant properties. It is an inhibitor of TETRAHYDROFOLATE DEHYDROGENASE and prevents the formation of tetrahydrofolate, necessary for synthesis of thymidylate, an essential component of DNA.

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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