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1. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients over 60 years of age: a prospective phase II study

Author

Kröger, Nicolaus, primary, Wulf, Gerald, additional, Hegenbart, Ute, additional, Burchert, Andreas, additional, Stelljes, Matthias, additional, Gagelmann, Nico, additional, Brecht, Arne, additional, Kaufmann, Martin, additional, Müller, Lutz, additional, Ganser, Arnold, additional, Wolf, Dominik, additional, Bethge, Wolfgang, additional, Bornhäuser, Martin, additional, Kiehl, Michael, additional, Wagner, Eva-Maria, additional, Schmid, Christoph, additional, Reinhardt, Christian, additional, Kobbe, Guido, additional, Salwender, Hans, additional, Heinicke, Thomas, additional, Kropff, Martin, additional, Heinzelmann, Marion, additional, Ayuk, Francis, additional, Trümper, Lorenz, additional, Neubauer, Andreas, additional, Völp, Andreas, additional, Kluychnikov, Evgeny, additional, Schönland, Stefan, additional, and Wolschke, Christine, additional

Published
2023
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2. GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study

Author

Bonifazi, Francesca, Solano, Carlos, Wolschke, Christine, Sessa, Mariarosaria, Patriarca, Francesca, Zallio, Francesco, Nagler, Arnon, Selleri, Carmine, Risitano, Antonio Maria, Messina, Giuseppe, Bethge, Wolfgang, Herrera, Pilar, Sureda, Anna, Carella, Angelo Michele, Cimminiello, Michele, Guidi, Stefano, Finke, Jürgen, Sorasio, Roberto, Ferra, Christelle, Sierra, Jorge, Russo, Domenico, Benedetti, Edoardo, Milone, Giuseppe, Benedetti, Fabio, Heinzelmann, Marion, Pastore, Domenico, Jurado, Manuel, Terruzzi, Elisabetta, Narni, Franco, Völp, Andreas, Ayuk, Francis, Ruutu, Tapani, and Kröger, Nicolaus

Published
2019
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3. Impact of High-Risk Cytogenetics and Achievement of Molecular Remission on Long-Term Freedom from Disease after Autologous–Allogeneic Tandem Transplantation in Patients with Multiple Myeloma

Author

Kröger, Nicolaus, Badbaran, Anita, Zabelina, Tatjana, Ayuk, Francis, Wolschke, Christine, Alchalby, Haefaa, Klyuchnikov, Evgeny, Atanackovic, Djordje, Schilling, Georgia, Hansen, Timon, Schwarz, Sabine, Heinzelmann, Marion, Zeschke, Silke, Bacher, Ulrike, Stübig, Thomas, Fehse, Boris, and Zander, Axel R.

Published
2013
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4. Supplement to: Antilymphocyte globulin for prevention of chronic graft-versus-host disease.

Author

Kröger, Nicolaus, Solano, Carlos, Wolschke, Christine, Bandini, Giuseppe, Patriarca, Francesca, Pini, Massimo, Nagler, Arnon, Selleri, Carmine, Risitano, Antonio, 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, Andreas, Ayuk, Francis, Ruutu, Tapani, and Bonifazi, Francesca

Published
2016

5. Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study)

Author

Kröger, Nicolaus, primary, Sockel, Katja, additional, Wolschke, Christine, additional, Bethge, Wolfgang, additional, Schlenk, Richard F., additional, Wolf, Dominik, additional, Stadler, Michael, additional, Kobbe, Guido, additional, Wulf, Gerald, additional, Bug, Gesine, additional, Schäfer-Eckart, Kerstin, additional, Scheid, Christof, additional, Nolte, Florian, additional, Krönke, Jan, additional, Stelljes, Matthias, additional, Beelen, Dietrich, additional, Heinzelmann, Marion, additional, Haase, Detlef, additional, Buchner, Hannes, additional, Bleckert, Gabriele, additional, Giagounidis, Aristoteles, additional, and Platzbecker, Uwe, additional

Published
2021
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6. P-175: Outcomes of autologous-allogeneic vs autologous tandem approach followed by thalidomide maintenance for transplant-eligible patients with newly diagnosed multiple myeloma: a prospective phase II-study

Author

Gagelmann, Nico, primary, Hegenbart, Ute, additional, Stelljes, Matthias, additional, Kaufmann, Martin, additional, Müller, Lutz, additional, Ganser, Arnold, additional, Schmid, Christoph, additional, Kobbe, Guido, additional, Wagner, Eva, additional, Bornhäuser, Martin, additional, Kiehl, Michael, additional, Wulf, Gerald, additional, Bethge, Wolfgang, additional, Burchert, Andreas, additional, Wolf, Dominik, additional, Heinicke, Thomas, additional, Heinzelmann, Marion, additional, Wolschke, Christine, additional, Völp, Andreas, additional, Schönland, Stefan, additional, and Kröger, Nicolaus, additional

Published
2021
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7. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease

Author

Kröger, Nicolaus, Solano, Carlos, Wolschke, Christine, Bandini, Giuseppe, Patriarca, Francesca, Pini, Massimo, Nagler, Arnon, Selleri, Carmine, Risitano, Antonio, Messina, Giuseppe, Bethge, Wolfgang, Pérez de Oteiza, Jaime, 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, Andreas, Ayuk, Francis, Ruutu, Tapani, and Bonifazi, Francesca

Published
2016
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9. Reduced intensity allogeneic stem cell transplantation for younger patients with myelofibrosis

Author

Mannina, Daniele, primary, Zabelina, Tatjana, additional, Wolschke, Christine, additional, Heinzelmann, Marion, additional, Triviai, Ioanna, additional, Christopeit, Maximilian, additional, Badbaran, Anita, additional, Bonmann, Stefan, additional, von Pein, Ute‐Marie, additional, Janson, Dietlinde, additional, Ayuk, Francis, additional, and Kröger, Nicolaus, additional

Published
2019
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10. Prospective Multicenter Phase 3 Study Comparing 5-Azacytidine (5-Aza) Induction Followed By Allogeneic Stem Cell Transplantation Versus Continuous 5-Aza According to Donor Availability in Elderly MDS Patients (55-70 years) (VidazaAllo Study)

Author

Kroeger, Nicolaus, primary, Sockel, Katja, additional, Wolschke, Christine, additional, Bethge, Wolfgang, additional, Schlenk, Richard F., additional, Wolf‎, Dominik, additional, Stadler, Michael, additional, Kobbe, Guido, additional, Wulf, Gerald, additional, Bug, Gesine, additional, Schäfer-Eckart, Kerstin, additional, Scheid, Christoph, additional, Nolte, Florian, additional, Krönke, Jan, additional, Stelljes, Matthias, additional, Beelen, Dietrich W., additional, Heinzelmann, Marion, additional, Haase, Detlef, additional, Buchner, Hannes, additional, Bleckert, Gabriele, additional, and Platzbecker, Uwe, additional

Published
2018
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11. Anti-T Lymphocyte Globulin (ATLG) Improves Quality of Life (QoL) and Chronic Graft vs Host Disease and Relapse Free Survival (GRFS) after Allogeneic Hematopoietic Stem Cell Transplantation from Hla-Identical Sibling in Acute Myeloid Leukemia: Final Results of QoL and Long-Term Outcome Analysis of a Phase 3 Randomized Study

Author

Bonifazi, Francesca, primary, Solano, Carlos, additional, Wolschke, Christine, additional, Sessa, Mariarosaria, additional, Patriarca, Francesca, additional, Zallio, Francesco, additional, Nagler, Arnon, additional, Selleri, Carmine, additional, Risitano, Antonio Maria, additional, Messina, Giuseppe, additional, Bethge, Wolfgang, additional, Herrera, Pilar, additional, Sureda, Anna, additional, Carella, Angelo Michelle, additional, Cimminiello, Michele, additional, Guidi, Stefano, additional, Finke, Jürgen, additional, Sorasio, Roberto, additional, Ferra, Christelle, additional, Sierra, Jorge, additional, Russo, Domenico, additional, Benedetti, Edoardo, additional, Milone, Giuseppe, additional, Benedetti, Fabio, additional, Heinzelmann, Marion, additional, Pastore, Domenico, additional, Jurado, Manuel, additional, Terruzzi, Elisabetta, additional, Narni, Franco, additional, Völp, Andreas, additional, Ayuk, Francis, additional, Ruutu, Tapani, additional, and Kröger, Nicolaus, additional

Published
2018
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12. Prevention of Chronic GvHD after HLA-Identical Sibling Peripheral Hematopietic Stem Cell Transplantation with or without Anti-Lymphocyte Globulin (ATG). Results from a Prospective, Multicenter Randomized Phase III Trial (ATGfamilystudy)

Author

Bonifazi, Francesca, primary, Solano, Carlos, additional, Wolschke, Christine, additional, Patriarca, Francesca, additional, Pini, Massimo, additional, Nagler, Arnon, additional, Selleri, Mino, additional, Messina, Giuseppe, additional, Bethge, Wolfgang A., additional, Fuente, Pilar Herrera, additional, Duarte, Rafael F, additional, Cascavilla, Nicola, additional, Cimminiello, Michele, additional, Guidi, Stefano, additional, Finke, Jürgen, additional, Gallamini, Andrea, additional, Ferrà, Christelle, additional, Sierra, Jorge, additional, Russo, Domenico, additional, Petrini, Mario, additional, Milone, Giuseppe, additional, Benedetti, Fabio, additional, Heinzelmann, Marion, additional, Liso, Vincenzo, additional, Jurado, Manuel, additional, Pogliani, Enrico Maria, additional, Narni, Franco, additional, Völp, Andreas, additional, Bandini, Giuseppe, additional, Ayuk, Francis, additional, and Kröger, Nicolaus, additional

Published
2014
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14. Postallograft lenalidomide induces strong NK cell–mediated antimyeloma activity and risk for T cell–mediated GvHD: Results from a phase I/II dose-finding study

Author

Wolschke, Christine, primary, Stübig, Thomas, additional, Hegenbart, Ute, additional, Schönland, Stefan, additional, Heinzelmann, Marion, additional, Hildebrandt, York, additional, Ayuk, Francis, additional, Atanackovic, Djordje, additional, Dreger, Peter, additional, Zander, Axel, additional, and Kröger, Nicolaus, additional

Published
2013
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16. Unrelated stem cell transplantation after reduced intensity conditioning for patients with multiple myeloma relapsing after autologous transplantation

Author

Kröger, Nicolaus, primary, Shimoni, Avichai, additional, Schilling, Georgia, additional, Schwerdtfeger, Rainer, additional, Bornhäuser, Martin, additional, Nagler, Arnon, additional, Zander, Axel R., additional, Heinzelmann, Marion, additional, Brand, Ronald, additional, Gahrton, Gösta, additional, Morris, Curly, additional, Niederwieser, Dietger, additional, and De Witte, Theo, additional

Published
2009
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17. Related Vs Unrelated Donors After Auto-Allo Tandem Stem Cell Transplantation for Newly Diagnosed Patients with Multiple Myeloma.

Author

Kröger, Nicolaus, primary, Zabelina, Tatjana, additional, Heinzelmann, Marion, additional, Schilling, Georgia, additional, Wolschke, Christine, additional, Lellek, Heinrich, additional, Stübig, Thomas, additional, Lestin, Maite, additional, Alchalby, Haefaa, additional, Ayuk, Francis, additional, Atanackovic, Djordje, additional, Bacher, Ulrike, additional, Fehse, Boris, additional, and Zander, Axel R., additional

Published
2009
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18. Dose-Reduced Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients with Myelofibrosis. Results from a Multicenter Prospective Trial of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT).

Author

Kroeger, Nicolaus, primary, Holler, Ernst, additional, Kobbe, Guido, additional, Bornhaeuser, Martin, additional, Schwerdtfeger, Rainer, additional, Nagler, Arnon, additional, Bethge, Wolfgang, additional, Stelljes, Matthias, additional, Uharek, Lutz, additional, Wandt, Hannes, additional, van Os, Marleen, additional, Burchert, Andreas, additional, Corradini, Paolo, additional, Schubert, Joerg, additional, Kaufmann, Martin, additional, Dreger, Peter, additional, Wulf, Gerald, additional, Einsele, Hermann, additional, Gramatzki, Martin, additional, Zabelina, Tatjana, additional, Bacher, Ulrike, additional, Zander, Axel, additional, Heinzelmann, Marion, additional, Kvasnicka, Michael, additional, Thiele, Juergen, additional, Niederwieser, Dietger, additional, and de Witte, Theo, additional

Published
2007
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21. Early In Vivo Depletion of Suicide Gene-Modified T-Lymphocytes Transplanted in Conjunction with CD34+ Enriched Blood Stem Cells May Be Associated with an Increased Risk of Secondary Graft Failure.

Author

Fehse, Boris, primary, Ayuk, Francis A., additional, Kröger, Nicolaus, additional, Fang, Lubin, additional, Kühlcke, Klaus, additional, Heinzelmann, Marion, additional, Zabelina, Tatjana, additional, Fauser, Axel A., additional, and Zander, Axel R., additional

Published
2004
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22. 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, Boris, primary, Ayuk, Francis A., additional, Kröger, Nicolaus, additional, Fang, Lubin, additional, Kühlcke, Klaus, additional, Heinzelmann, Marion, additional, Zabelina, Tatjana, additional, Fauser, Axel A., additional, and Zander, Axel R., additional

Published
2004
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23. Early In Vivo Depletion of Suicide Gene-Modified T-Lymphocytes Transplanted in Conjunction with CD34+Enriched Blood Stem Cells May Be Associated with an Increased Risk of Secondary Graft Failure.

Author

Fehse, Boris, Ayuk, Francis A., Kröger, Nicolaus, Fang, Lubin, Kühlcke, Klaus, Heinzelmann, Marion, Zabelina, Tatjana, Fauser, Axel A., and Zander, Axel R.

Abstract

Introduction of a “suicide gene” into donor T-lymphocytes is a promising strategy to prevent severe graft-versus-host disease (GvHD) in the setting of allogeneic blood stem cell transplantation (B-SCT). We initiated a clinical phase I/II-study combining CD34-enriched peripheral B-SCT and Herpes simplex virusthymidine kinase- (HSV-tk) transduced donor T-cell infusions at days 0 and (optional) 60. Before our study was put on hold (after the leukemia cases in the French X-SCID trial) three patients were treated within the protocol each receiving >4x106/kg highly enriched CD34+and appr. 5x106/kg suicide gene-modified (SGM) donor T-cells. All patients showed fast donor cell engraftment. Patient 2 (without signs of GvHD) received two SGM T-cell infusions and is well >2.5 years thereafter. Patient 1, showed an early (days 11–13) strong increase of SGM cell-counts peaking at 7.2x107/l, but did not develop GvHD. Unexpectedly, his blood was completely cleared from SGM T-lymphocytes a few days later. This patient received a second dose of SGM T-cells (day 65), which vanished within 2 days strongly indicative of their immune rejection. Indeed, MLRdata confirmed anti-SGM reactivity of this patient's PBL possibly related to an HSVreactivation during transplantation. Patient 3 showed a similar early sharp rise in SGM T-cells (days 14–17), in his case associated with acute skin GvHD grade II. Treatment with ganciclovir led to complete resolution of GvHD and rapid disappearance of SGM donor T-cells. Importantly, both patients 1 and 3 developed secondary graft failure at days 156 and 119. In summary, we confirmed previous reports that the use of SGM T-lymphocytes may allow control of acute GVHD. At the same time, we made the worrying observation that early total in vivodepletion of SGM donor T-cells may be associated with an increased risk of transplant rejection. This suggests that minimum numbers of donor CD3+cells are required post-transplant not only to facilitate engraftment, but also to prevent late rejection.

Published
2004
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24. Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission : final results of quality of life and long-term outcome analysis of a phase 3 randomised study

Author

Francesca, Bonifazi, Carlos, Solano, Christine, Wolschke, Mariarosaria, Sessa, Francesca, Patriarca, Francesco, Zallio, Arnon, Nagler, Carmine, Selleri, Antonio Maria, Risitano, Giuseppe, Messina, Wolfgang, Bethge, Pilar, Herrera, Anna, Sureda, Angelo Michele, Carella, Michele, Cimminiello, Stefano, Guidi, Jürgen, Finke, Roberto, Sorasio, Christelle, Ferra, Jorge, Sierra, Domenico, Russo, Edoardo, Benedetti, Giuseppe, Milone, Fabio, Benedetti, Marion, Heinzelmann, Domenico, Pastore, Manuel, Jurado, Elisabetta, Terruzzi, Franco, Narni, Andreas, Völp, Francis, Ayuk, Tapani, Ruutu, Nicolaus, Kröger, Department of Medicine, Clinicum, HUS Comprehensive Cancer Center, Bonifazi, Francesca, Solano, Carlo, Wolschke, Christine, Sessa, Mariarosaria, Patriarca, Francesca, Zallio, Francesco, Nagler, Arnon, Selleri, Carmine, Risitano, Antonio Maria, Messina, Giuseppe, Bethge, Wolfgang, Herrera, Pilar, Sureda, Anna, Carella, Angelo Michele, Cimminiello, Michele, Guidi, Stefano, Finke, Jürgen, Sorasio, Roberto, Ferra, Christelle, Sierra, Jorge, Russo, Domenico, Benedetti, Edoardo, Milone, Giuseppe, Benedetti, Fabio, Heinzelmann, Marion, Pastore, Domenico, Jurado, Manuel, Terruzzi, Elisabetta, Narni, Franco, Völp, Andrea, Ayuk, Franci, Ruutu, Tapani, and Kröger, Nicolaus

Subjects
Adult, Male, Sibling, allogeneic transplant, GVHD, Adolescent, MATCHED UNRELATED DONORS, GVHD, MULTICENTER, Graft vs Host Disease, END-POINT, HEMATOLOGICAL MALIGNANCIES, Disease-Free Survival, Young Adult, HLA Antigens, T-LYMPHOCYTE GLOBULIN, VERSUS-HOST-DISEASE, Humans, HLA Antigen, Aged, Antilymphocyte Serum, Siblings, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, allogeneic transplant, RELAPSE-FREE SURVIVAL, OPEN-LABEL, ANTI-THYMOCYTE GLOBULIN, Leukemia, Myeloid, Acute, MARROW, 3121 General medicine, internal medicine and other clinical medicine, Quality of Life, Female, Human
Abstract

We previously showed that human anti-T-lymphocyte globulin (ATLG) plus ciclosporin and methotrexate given to patients with acute leukaemia in remission, having allogeneic haemopoietic stem-cell transplantation with peripheral blood stem cells from an HLA-identical sibling donor after myeloablative conditioning, significantly reduced 2-year chronic graft-versus-host disease (cGVHD) incidence and severity, without increasing disease relapse and infections, and improves cGVHD-free and relapse-free survival (cGRFS). The aim of an extended follow-up study was the assessment of long-term outcomes, which are, in this context, scarcely reported in the literature. We report unpublished data on quality of life (QoL) from the original study and the results of a follow-up extension.In the original open-label study, patients with acute myeloid and lymphoblastic leukaemia in first or subsequent remission, having sibling HLA-identical allogeneic peripheral blood stem-cell transplantation, were randomly assigned (1:1) to receive ATLG plus standard GVHD prophylaxis with ciclosporin and short-term methotrexate (ATLG group) or standard GVHD prophylaxis without ATLG (non-ATLG group). Conditioning regimens were cyclophosphamide 120 mg/kg with either total body irradiation (12 Gy) or busulfan (12·8 mg/kg intravenously or 16 mg/kg orally), with or without etoposide (30-60 mg/kg). Randomisation was stratified according to centre and disease risk. The primary endpoint was cumulative incidence of cGVHD at 2 years. The primary and secondary endpoints, excluding QoL, have been published. QoL, assessed using European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-HDC29 questionnaires, was an unpublished secondary endpoint, which we now report here. A follow-up extension was then done, with the primary endpoint cumulative incidence of cGVHD. Enrolment has been completed for both studies. The original trial (number, NCT00678275) and follow-up extension (number, NCT03042676) are registered at ClinicalTrials.gov.In the original study, from Dec 14, 2006, to Feb 2, 2012, 161 patients were enrolled and 155 were randomly assigned to either the ATLG group (n=83) or to the non-ATLG group (n=72). In the follow-up study, which started on Feb 7, 2017, and was completed on June 30, 2017, 61 patients were included in the ATLG group and 53 were included in the non-ATLG group. Global health status showed a more favourable time course in the ATLG group compared with the non-ATLG group (p=0·02; treatment by visit interaction). ATLG was descriptively superior to non-ATLG at 24 months for physical function (points estimate -14·8 [95% CI -26·4 to -3·1]; p=0·014) and social function (-19·1 [-38·0 to -0·2]; p=0·047), gastrointestinal side-effects (8·8 [2·5-15·1]; p=0·008) and effect on family (13·5 [1·2-25·8]; p=0·032). Extended follow-up (median 5·9 years [IQR 1·7-7·9]) confirmed a lower 5-year cGVHD incidence (30·0% [95% CI 21·4-41·9] vs 69·1% [59·1-80·1]; analysis for entire follow-up, p0·001), no increase in relapses (35·4% [26·4-47·5] vs 22·5% [14·6-34·7]; p=0·09), improved cGRFS (34·3% [24·2-44·5] vs 13·9% [7·1-22·9]; p=0·005), and fewer patients still in immunosuppression (9·6% vs 28·3%; p=0·017) in the ATLG group compared with the non-ATLG group. 5-year overall survival, relapse-free survival, and non-relapse mortality did not differ significantly between groups.The addition of ATLG to standard GVHD prophylaxis improves the probability of surviving without disease relapse and cGVHD after myeloablative peripheral blood stem-cell transplantation from an HLA-identical sibling donor for patients with acute leukaemia in remission. Further additional benefits are better QoL and shorter immunosuppressive treatment compared with standard GVHD prophylaxis without ATLG. Therefore, in this setting, ATLG plus standard GVHD prophylaxis should be preferred over the standard GVHD prophylaxis alone.Neovii Biotech.

Published
2019

25. 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

26. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective, phase II study.

Author

Kröger N, Wulf G, Hegenbart U, Burchert A, Stelljes M, Gagelmann N, Brecht A, Kaufmann M, Müller L, Ganser A, Wolf D, Bethge W, Bornhäuser M, Kiehl M, Wagner EM, Schmid C, Reinhardt HC, Kobbe G, Salwender H, Heinicke T, Kropff M, Heinzelmann M, Ayuk F, Trümper L, Neubauer A, Völp A, Kluychnikov E, Schönland S, and Wolschke C

Subjects
Humans, Middle Aged, Male, Female, Adult, Prospective Studies, Transplantation, Homologous, Treatment Outcome, Multiple Myeloma therapy, Multiple Myeloma mortality, Multiple Myeloma diagnosis, Thalidomide administration & dosage, Thalidomide therapeutic use, Hematopoietic Stem Cell Transplantation methods, Transplantation, Autologous, Maintenance Chemotherapy
Abstract

The role of autologous-allogeneic tandem stem cell transplantation (alloTSCT) followed by maintenance as upfront treatment for multiple myeloma is controversial. Between 2008 and 2014 a total of 217 multiple myeloma patients with a median age of 51 years were included by 20 German centers within an open-label, parallel-group, multicenter clinical trial to compare alloTSCT to autologous tandem transplantation (autoTSCT) followed by 2 years of maintenance therapy with thalidomide (100 mg/day) in both arms with respect to relapse/progression-free survival (PFS) and other relevant outcomes. A total of 178 patients underwent a second transplant (132 allogeneic, 46 autologous). PFS at 4 years after the second transplant was 47% (95% CI: 38-55%) for alloTSCT and 35% (95% CI: 21-49%) for autoTSCT (P=0.26). This difference increased to 22% at 8 years (P=0.10). The cumulative incidences of non-relapse mortality and of relapse at 4 years were 13% (95% CI: 8-20%) and 2% (95% CI: 0.3-2%) (P=0.044) and 40% (95% CI: 33-50%) and 63% (95% CI: 50-79%) (P=0.04) for alloTSCT and autoTSCT, respectively. The difference for relapse/progression increased to 33% (alloTSCT: 44%, autoTSCT: 77%) at a median follow-up of 82 months (P=0.002). Four-year overall survival was 66% (95% CI: 57-73%) for alloTSCT and 66% (95% CI: 50-78%) for autoTSCT (P=0.91) and 8-year overall survival was 52% and 50% (P=0.87), respectively. In conclusion, alloTSCT followed by thalidomide maintenance reduced the rate of recurrence or progression during a follow-up period of up to 10 years but failed to improve PFS significantly. This study was registered with ClinicalTrials.gov (NCT00777998).

Published
2024
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27. Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study.

Author

Bonifazi F, Solano C, Wolschke C, Sessa M, Patriarca F, Zallio F, Nagler A, Selleri C, Risitano AM, Messina G, Bethge W, Herrera P, Sureda A, Carella AM, Cimminiello M, Guidi S, Finke J, Sorasio R, Ferra C, Sierra J, Russo D, Benedetti E, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Völp A, Ayuk F, Ruutu T, and Kröger N

Subjects
Adolescent, Adult, Aged, Disease-Free Survival, Female, Graft vs Host Disease etiology, Humans, Leukemia, Myeloid, Acute immunology, Leukemia, Myeloid, Acute metabolism, Male, Middle Aged, Quality of Life, Young Adult, Antilymphocyte Serum immunology, Graft vs Host Disease prevention & control, HLA Antigens metabolism, Hematopoietic Stem Cell Transplantation adverse effects, Leukemia, Myeloid, Acute therapy, Siblings
Abstract

Background: We previously showed that human anti-T-lymphocyte globulin (ATLG) plus ciclosporin and methotrexate given to patients with acute leukaemia in remission, having allogeneic haemopoietic stem-cell transplantation with peripheral blood stem cells from an HLA-identical sibling donor after myeloablative conditioning, significantly reduced 2-year chronic graft-versus-host disease (cGVHD) incidence and severity, without increasing disease relapse and infections, and improves cGVHD-free and relapse-free survival (cGRFS). The aim of an extended follow-up study was the assessment of long-term outcomes, which are, in this context, scarcely reported in the literature. We report unpublished data on quality of life (QoL) from the original study and the results of a follow-up extension., Methods: In the original open-label study, patients with acute myeloid and lymphoblastic leukaemia in first or subsequent remission, having sibling HLA-identical allogeneic peripheral blood stem-cell transplantation, were randomly assigned (1:1) to receive ATLG plus standard GVHD prophylaxis with ciclosporin and short-term methotrexate (ATLG group) or standard GVHD prophylaxis without ATLG (non-ATLG group). Conditioning regimens were cyclophosphamide 120 mg/kg with either total body irradiation (12 Gy) or busulfan (12·8 mg/kg intravenously or 16 mg/kg orally), with or without etoposide (30-60 mg/kg). Randomisation was stratified according to centre and disease risk. The primary endpoint was cumulative incidence of cGVHD at 2 years. The primary and secondary endpoints, excluding QoL, have been published. QoL, assessed using European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-HDC29 questionnaires, was an unpublished secondary endpoint, which we now report here. A follow-up extension was then done, with the primary endpoint cumulative incidence of cGVHD. Enrolment has been completed for both studies. The original trial (number, NCT00678275) and follow-up extension (number, NCT03042676) are registered at ClinicalTrials.gov., Findings: In the original study, from Dec 14, 2006, to Feb 2, 2012, 161 patients were enrolled and 155 were randomly assigned to either the ATLG group (n=83) or to the non-ATLG group (n=72). In the follow-up study, which started on Feb 7, 2017, and was completed on June 30, 2017, 61 patients were included in the ATLG group and 53 were included in the non-ATLG group. Global health status showed a more favourable time course in the ATLG group compared with the non-ATLG group (p=0·02; treatment by visit interaction). ATLG was descriptively superior to non-ATLG at 24 months for physical function (points estimate -14·8 [95% CI -26·4 to -3·1]; p=0·014) and social function (-19·1 [-38·0 to -0·2]; p=0·047), gastrointestinal side-effects (8·8 [2·5-15·1]; p=0·008) and effect on family (13·5 [1·2-25·8]; p=0·032). Extended follow-up (median 5·9 years [IQR 1·7-7·9]) confirmed a lower 5-year cGVHD incidence (30·0% [95% CI 21·4-41·9] vs 69·1% [59·1-80·1]; analysis for entire follow-up, p<0·001), no increase in relapses (35·4% [26·4-47·5] vs 22·5% [14·6-34·7]; p=0·09), improved cGRFS (34·3% [24·2-44·5] vs 13·9% [7·1-22·9]; p=0·005), and fewer patients still in immunosuppression (9·6% vs 28·3%; p=0·017) in the ATLG group compared with the non-ATLG group. 5-year overall survival, relapse-free survival, and non-relapse mortality did not differ significantly between groups., Interpretation: The addition of ATLG to standard GVHD prophylaxis improves the probability of surviving without disease relapse and cGVHD after myeloablative peripheral blood stem-cell transplantation from an HLA-identical sibling donor for patients with acute leukaemia in remission. Further additional benefits are better QoL and shorter immunosuppressive treatment compared with standard GVHD prophylaxis without ATLG. Therefore, in this setting, ATLG plus standard GVHD prophylaxis should be preferred over the standard GVHD prophylaxis alone., Funding: Neovii Biotech., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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