Visilizumab with Tacrolimus and Methotrexate for Graft-Versus-Host Disease Prevention After Allogeneic Hematopoietic Cell Transplantation From Mismatched Unrelated Donors
methylprednisolone. Chronic GVHD requires continued immunosuppressive therapy plus other modifying agents. Sirolimus compared with prednisone may offer similar initial treatment efficacy, avoid steroid-associated toxicity, and improve patient-reported quality of life. [51] Monoclonal antibodies directed either against activated T cells (visilizumab, murine anti-CD147 monoclonal antibody [ABX-CBL]) or against
requires continued immunosuppressive therapy plus other modifying agents. Sirolimus compared with prednisone may offer similar initial treatment efficacy, avoid steroid-associated toxicity, and improve patient-reported quality of life. [51] Monoclonal antibodies directed either against activated T cells (visilizumab, murine anti-CD147 monoclonal antibody [ABX-CBL]) or against cytokines (infliximab
is a neurothelion member of the immunoglobulin superfamily and up-regulated on activated B cells and T cells, induced 50% response in steroid-resistant acute GVHD. Moderate-to-severe myalgia occurred in 28-60% of cases and was dose limiting. Visilizumab is a humanized anti-CD3 antibody that selectively induces apoptosis of activated T-cells. A phase I study demonstrated that all patients affected by severe acute GVHD and treated with visilizumab improved. However, posttransplant lymphoproliferative disease (PTLD) was a major concern. Also, extracorporeal photopheresis has been used to treat resistant, acute GVHD; the patients who responded had a significantly better outcome.Prevention and treatment of chronic graft versus host diseaseThe best prophylaxis against chronic GVHD is prevention of acute GVHD
requires continued immunosuppressive therapy plus other modifying agents. Sirolimus compared with prednisone may offer similar initial treatment efficacy, avoid steroid-associated toxicity, and improve patient-reported quality of life. [51] Monoclonal antibodies directed either against activated T cells (visilizumab, murine anti-CD147 monoclonal antibody [ABX-CBL]) or against cytokines (infliximab
methylprednisolone. Chronic GVHD requires continued immunosuppressive therapy plus other modifying agents. Sirolimus compared with prednisone may offer similar initial treatment efficacy, avoid steroid-associated toxicity, and improve patient-reported quality of life. [51] Monoclonal antibodies directed either against activated T cells (visilizumab, murine anti-CD147 monoclonal antibody [ABX-CBL]) or against
requires continued immunosuppressive therapy plus other modifying agents. Sirolimus compared with prednisone may offer similar initial treatment efficacy, avoid steroid-associated toxicity, and improve patient-reported quality of life. [51] Monoclonal antibodies directed either against activated T cells (visilizumab, murine anti-CD147 monoclonal antibody [ABX-CBL]) or against cytokines (infliximab
, and provide diagnostic and therapeutic algorithms. We critically review the evidence for established (5-aminosalicylic acid compounds, corticosteroids, immunomodulators, calcineurin inhibitors) and emerging novel therapies--including biological therapies--directed at cytokines (eg, infliximab, adalimumab, certolizumab pegol) and receptors (eg, visilizumab, abatacept) involved in T-cell activation, selective
Transient cytokine-induced liver injury following administration of the humanized anti-CD3 antibody visilizumab (HuM291) in Crohn's disease. Monoclonal antibodies to CD3 and CD4 T-cell receptors are evolving for Crohn's disease (CD) and ulcerative colitis. Their administration is often associated with a cytokine release syndrome (CRS). We evaluated data from two prospective clinical trials (NCT00267709 and NCT00267722) of visilizumab (HuM291), a novel humanized anti-CD3 antibody, in 34 patients with CD who received 10 microg/kg intravenously on 2 consecutive days. Serum hepatic tests including bilirubin, alkaline phosphatase (AP), gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT) and aspartate aminotransferase (AST), visilizumab concentrations, and a panel of 16 cytokines were
Prospective randomized open-label multicenter phase I/II dose escalation trial of visilizumab (HuM291) in severe steroid-refractory ulcerative colitis. Visilizumab is a humanized IgG(2) monoclonal anti-CD3 antibody. We evaluated its safety and dose response in severe intravenous steroid-refractory ulcerative colitis (UC). In all, 104 patients were treated. In Stage I, 73 patients were randomly assigned to receive intravenous visilizumab 5, 7.5, 10, or 12.5 microg/kg/day for 2 consecutive days. In Stage II, 33 patients received visilizumab at the optimal clinical dose (OCD) of 5 microg/kg/day for 2 days. Symptomatic response and remission were defined by the modified Truelove-Witts severity index. Clinical response and remission were defined by the Mayo score. The rates of symptomatic response
Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis Pilot studies with visilizumab, a humanised monoclonal antibody to CD3, suggest efficacy for corticosteroid-refractory ulcerative colitis (UC). A placebo-controlled trial was warranted. A randomised, double-blind, placebo-controlled study evaluated the efficacy of visilizumab induction treatment in 127 patients with severely active UC despite treatment with ≥5 days of intravenous corticosteroids. Patients received placebo or visilizumab 5μg/kg intravenously on days 1 and 2. Corticosteroids were tapered according to disease activity. Patients were followed up for 90 days. The primary end point was induction of response at day 45. Secondary end points included remission
therapy in treating patients who have advanced or recurrent lymphoma.Condition or disease Intervention/treatment Phase Lymphoma Small Intestine Cancer Biological: visilizumab Phase 1 Detailed Description: OBJECTIVES: * Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas. * Evaluate Intestinal Diseases Lymphatic Diseases Visilizumab Immunoproliferative Disorders Immunologic Factors Immune System Diseases Physiological Effects of Drugs Gastrointestinal Neoplasms To Top * For Patients and Families * For Researchers * For Study Record Managers * Home * RSS Feeds * Site Map
Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data WarningYou have reached the maximum number of saved studies (100).Please remove one or more studies before adding more. Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal
Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting studies (100).Please remove one or more studies before adding more. Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov
Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element reached the maximum number of saved studies (100).Please remove one or more studies before adding more. Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our
Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting registration or results information ).Please remove one or more studies before adding more. Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT00267709
A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions the maximum number of saved studies (100).Please remove one or more studies before adding more. A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more * Disclaimer * PRS Login * Home * Search Results * Study Record DetailSaved Studies Save this study WarningYou have reached the maximum number of saved studies (100).Please remove one or more studies before adding more. Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study The safety and scientific validity