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RESEARCH PRODUCT
Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease.
Fabio BenedettiAngelo Michele CarellaMichele CimminielloElisabetta TerruzziJaime Pérez De OteyzaKröger NFrancesca BonifaziNicola MordiniRafael F. DuarteJorge SierraJürgen FinkeFrancesca PatriarcaChristine WolschkeCarlos SolanoFranco NarniAntonio M. RisitanoDomenico PastoreWolfgang BethgeFrancis AyukMario PetriniCarmine SelleriCarmine SelleriTapani RuutuGiuseppe MessinaArnon NaglerAndreas VölpChristelle FerraMarion HeinzelmannMassimo PiniGiuseppe BandiniManuel JuradoGiuseppe MiloneDomenico RussoStefano Guidisubject
Male:Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Models Statistical::Proportional Hazards Models [Medical Subject Headings]T-LymphocytesPhases of clinical researchGraft vs Host Disease:Named Groups::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings]Linfocitos t:Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings]Immunosuppressive Agent0302 clinical medicineTrasplante homólogoEstudios prospectivosMedicineCumulative incidenceProspective StudiesProspective cohort studyChildTransplantation Homologou:Chemicals and Drugs::Amino Acids Peptides and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immune Sera::Antilymphocyte Serum [Medical Subject Headings]Acute leukemia:Anatomy::Cells::Blood Cells::Leukocytes::Leukocytes Mononuclear::Lymphocytes::T-Lymphocytes [Medical Subject Headings]:Diseases::Pathological Conditions Signs and Symptoms::Pathologic Processes::Disease Attributes::Chronic Disease [Medical Subject Headings]:Named Groups::Persons::Age Groups::Child::Child Preschool [Medical Subject Headings]Medicine (all)IncidenceSuero antilinfocíticoGeneral MedicineMiddle AgedModelos de riesgos proporcionales3. Good healthHumanosSurvival Rate030220 oncology & carcinogenesis:Named Groups::Persons::Age Groups::Adolescent [Medical Subject Headings]Child PreschoolFemale:Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Immunosuppressive Agents [Medical Subject Headings]Immunosuppressive AgentsHumanHomologousAdultmedicine.medical_specialty:Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Prospective Studies [Medical Subject Headings]:Named Groups::Persons::Age Groups::Adult::Young Adult [Medical Subject Headings]AdolescentEnfermedad injerto contra huéspedDisease-Free Survival03 medical and health sciencesYoung AdultInternal medicine:Named Groups::Persons::Age Groups::Adult [Medical Subject Headings]HumansTransplantation HomologousSupervivencia sin enfermedadPreschoolSurvival rate:Analytical Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Disease-Free Survival [Medical Subject Headings]:Named Groups::Persons::Age Groups::Child [Medical Subject Headings]Antilymphocyte SerumProportional Hazards ModelsTransplantationbusiness.industryEnfermedad crónicamedicine.diseaseInmunosupresoresAnti-thymocyte globulinSurgeryTransplantation:Diseases::Immune System Diseases::Graft vs Host Disease [Medical Subject Headings]Prospective Studie:Analytical Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures Operative::Transplantation::Transplantation Homologous [Medical Subject Headings]Graft-versus-host diseaseT-Lymphocyte:Check Tags::Female [Medical Subject Headings]Chronic DiseaseProportional Hazards ModelAdolescent; Adult; Antilymphocyte Serum; Child; Child Preschool; Chronic Disease; Disease-Free Survival; Female; Graft vs Host Disease; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Proportional Hazards Models; Prospective Studies; Survival Rate; T-Lymphocytes; Transplantation Homologous; Young Adult; Medicine (all)business030215 immunologydescription
Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; BACKGROUND Chronic graft-versus-host disease (GVHD) is the leading cause of later illness and death after allogeneic hematopoietic stem-cell transplantation. We hypothesized that the inclusion of antihuman T-lymphocyte immune globulin (ATG) in a myeloablative conditioning regimen for patients with acute leukemia would result in a significant reduction in chronic GVHD 2 years after allogeneic peripheral-blood stem-cell transplantation from an HLA-identical sibling. METHODS We conducted a prospective, multicenter, open-label, randomized phase 3 study of ATG as part of a conditioning regimen. A total of 168 patients were enrolled at 27 centers. Patients were randomly assigned in a 1:1 ratio to receive ATG or not receive ATG, with stratification according to center and risk of disease. RESULTS After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was 32.2% (95% confidence interval [CI], 22.1 to 46.7) in the ATG group and 68.7% (95% CI, 58.4 to 80.7) in the non-ATG group (P<0.001). The rate of 2-year relapse-free survival was similar in the ATG group and the non-ATG group (59.4% [95% CI, 47.8 to 69.2] and 64.6% [95% CI, 50.9 to 75.3], respectively; P=0.21), as was the rate of overall survival (74.1% [95% CI, 62.7 to 82.5] and 77.9% [95% CI, 66.1 to 86.1], respectively; P=0.46). There were no significant between-group differences in the rates of relapse, infectious complications, acute GVHD, or adverse events. The rate of a composite end point of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than in the non-ATG group (36.6% vs. 16.8%, P=0.005). CONCLUSIONS The inclusion of ATG resulted in a significantly lower rate of chronic GVHD after allogeneic transplantation than the rate without ATG. The survival rate was similar in the two groups, but the rate of a composite end point of chronic GVHD-free survival and relapse-free survival was higher with ATG. (Funded by the Neovii Biotech and the European Society for Blood and Marrow Transplantation; ClinicalTrials.gov number, NCT00678275.). Yes
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2016-01-07 |