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3 results on '"Heinzelmann, Marion"'

1. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease.

Author

Kröger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, Nagler A, Selleri C, Risitano A, Messina G, Bethge W, Pérez de Oteiza J, Duarte R, Carella AM, Cimminiello M, Guidi S, Finke J, Mordini N, Ferra C, Sierra J, Russo D, Petrini M, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Völp A, Ayuk F, Ruutu T, and Bonifazi F

Subjects
Adolescent, Adult, Child, Child, Preschool, Chronic Disease, Disease-Free Survival, Female, Graft vs Host Disease epidemiology, Graft vs Host Disease mortality, Humans, Incidence, Male, Middle Aged, Proportional Hazards Models, Prospective Studies, Survival Rate, Transplantation, Homologous, Young Adult, Antilymphocyte Serum therapeutic use, Graft vs Host Disease prevention & control, Immunosuppressive Agents therapeutic use, T-Lymphocytes immunology
Abstract

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.).

Published
2016
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2. Evidence for increased risk of secondary graft failure after in vivo depletion of suicide gene-modified T lymphocytes transplanted in conjunction with CD34+-enriched blood stem cells.

Author

Fehse B, Ayuk FA, Kröger N, Fang L, Kühlcke K, Heinzelmann M, Zabelina T, Fauser AA, and Zander AR

Subjects
Adult, Antigens, CD34, Female, Humans, Male, Middle Aged, Risk Factors, Adoptive Transfer, Genes, Transgenic, Suicide, Graft Rejection epidemiology, Graft vs Host Disease epidemiology, Stem Cell Transplantation, T-Lymphocytes physiology
Published
2004
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3. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease

Author

Fabio Benedetti, Angelo Michele Carella, Michele Cimminiello, Elisabetta Terruzzi, Jaime Pérez De Oteiza, Kröger N, Francesca Bonifazi, Nicola Mordini, Rafael F. Duarte, Jorge Sierra, Jürgen Finke, Francesca Patriarca, Christine Wolschke, Carlos Solano, Franco Narni, Antonio M. Risitano, Domenico Pastore, Wolfgang Bethge, Francis Ayuk, Mario Petrini, Carmine Selleri, Tapani Ruutu, Giuseppe Messina, Arnon Nagler, Andreas Völp, Christelle Ferra, Marion Heinzelmann, Massimo Pini, Giuseppe Bandini, Manuel Jurado, Giuseppe Milone, Domenico Russo, Stefano Guidi, [Kröge,N, Wolschke ,C, Heinzelmann,M, Ayuk,F ] University Medical Center Hamburg-Eppendorf,Hamburg, Germany. [Finke,J] University Hospital Freiburg, Freiburg ,Germany. [Bethge,W] University Hospital Tübingen, Tübingen, Germany. [Völp,A] Psy Consult, Frankfurt, Germany. [Solano,C] Hospital Clinico Universitario, Valencia, Spain. [Pérez de Oteiza,J] Hospital Ramon y Cajal, Madrid, Spain. [Duarte,R] Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain. [Ferra,C] Servicio de Hematología, Institut Català d’Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain. [Sierra,J] Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Jurado,M] Hospital Virgen de las Nieves, Granada, Spain. [Bandini,G, Bonifaz,F] Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy. [Patriarca,F] Hematology, DISM, University Udine, Udine. Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo, Alessandria, Italy. [Pini,M] Università Federico II di Napoli, Naples, Italy. [Selleri,C, Risitano,A) A.O. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy. [Messina,G] Ospedale Casa Sollievo della Sofferenza IRCCCS, San Giovanni Rotondo, Italy. [Carella,AM] Azienda Ospedaliera San Carlo, Potenza, Italy. [Cimminiello,M] Azienda Ospedaliera Careggi, Florence, Italy. [Guido,E] Ospedale Santa Croce, e Carle, Cuneo, Italy. [Mordini,N] University of Brescia, Department of Clinical and Experimental Sciences, Brescia, Italy. [Russo,D] University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy. [Petrini,M] Programma di Trapianto Emopoietico Metropolitano, Azienda Policlinico-Vittorio Emanuele, Catania, Italy. [Milone,R] Policlinico G.B. Rossi, Verona, Italy. [Benedetti,F] Azienda Ospedaliera, Universitaria Ospedale, Bari, Italy. [Pastore,D] Ospedale San Gerardo, Monza, Italy. [Terruzzi,E] Policlinico Modena, Modena, Italy. [Narni,F] Università di Salerno, Salerno, Italy. [Nagler,A] Chaim Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel. [Tapani,R] Helsinki University Hospital, Helsinki., Supported by a research grant from Neovii Biotech and by the European Society for Blood and Marrow Transplantation (EBMT) as an EBMT-labeled-study of the Chronic Malignancies Working Party., Kröger, Nicolau, Solano, Carlo, Wolschke, Christine, Bandini, Giuseppe, Patriarca, Francesca, Pini, Massimo, Nagler, Arnon, Selleri, Carmine, Risitano, ANTONIO MARIA, Messina, Giuseppe, Bethge, Wolfgang, De Oteiza, Jaime Pérez, Duarte, Rafael, Carella, Angelo Michele, Cimminiello, Michele, Guidi, Stefano, Finke, Jürgen, Mordini, Nicola, Ferra, Christelle, Sierra, Jorge, Russo, Domenico, Petrini, Mario, Milone, Giuseppe, Benedetti, Fabio, Heinzelmann, Marion, Pastore, Domenico, Jurado, Manuel, Terruzzi, Elisabetta, Narni, Franco, Völp, Andrea, Ayuk, Franci, Ruutu, Tapani, and Bonifazi, Francesca

Subjects
Male, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Models, Statistical::Proportional Hazards Models [Medical Subject Headings], T-Lymphocytes, Phases of clinical research, Graft 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 Agent, 0302 clinical medicine, Trasplante homólogo, Estudios prospectivos, Medicine, Cumulative incidence, Prospective Studies, Prospective cohort study, Child, Transplantation, 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), Incidence, Suero antilinfocítico, General Medicine, Middle Aged, Modelos de riesgos proporcionales, 3. Good health, Humanos, Survival Rate, 030220 oncology & carcinogenesis, Named Groups::Persons::Age Groups::Adolescent [Medical Subject Headings], Child, Preschool, Female, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Immunosuppressive Agents [Medical Subject Headings], Immunosuppressive Agents, Human, Homologous, Adult, medicine.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], Adolescent, Enfermedad injerto contra huésped, Disease-Free Survival, 03 medical and health sciences, Young Adult, Internal medicine, Named Groups::Persons::Age Groups::Adult [Medical Subject Headings], Humans, Transplantation, Homologous, Supervivencia sin enfermedad, Preschool, Survival 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 Serum, Proportional Hazards Models, Transplantation, business.industry, Enfermedad crónica, medicine.disease, Inmunosupresores, Anti-thymocyte globulin, Surgery, 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 disease, T-Lymphocyte, Check Tags::Female [Medical Subject Headings], Chronic Disease, Proportional Hazards Model, business, 030215 immunology
Abstract

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

Published
2016

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