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2. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial

Author

Hagenbeek, Anton, Gadeberg, Ole, Johnson, Peter, Møller Pedersen, Lars, Walewski, Jan, Hellmann, Andrzej, Link, Brian K., Robak, Tadeusz, Wojtukiewicz, Marek, Pfreundschuh, Michael, Kneba, Michael, Engert, Andreas, Sonneveld, Pieter, Flensburg, Mimi, Petersen, Jørgen, Losic, Nedjad, and Radford, John

Published
2008
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6. Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1–2 study

Author

Coiffier, Bertrand, Losic, Nedjad, Rønn, Birgitte Biilmann, Lepretre, Stéphane, Pedersen, Lars Møller, Gadeberg, Ole, Frederiksen, Henrik, van Oers, Marinus H. J., Wooldridge, James, Kloczko, Janusz, Holowiecki, Jerzy, Hellmann, Andrzej, Walewski, Jan, Robak, Tadeusz, and Petersen, Jørgen

Published
2010
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12. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study

Author

Sehn, Laurie H., primary, Goy, Andre, additional, Offner, Fritz C., additional, Martinelli, Giovanni, additional, Caballero, M. Dolores, additional, Gadeberg, Ole, additional, Baetz, Tara, additional, Zelenetz, Andrew D., additional, Gaidano, Gianluca, additional, Fayad, Luis E., additional, Buckstein, Rena, additional, Friedberg, Jonathan W., additional, Crump, Michael, additional, Jaksic, Branimir, additional, Zinzani, Pier Luigi, additional, Padmanabhan Iyer, Swaminathan, additional, Sahin, Deniz, additional, Chai, Akiko, additional, Fingerle-Rowson, Günter, additional, and Press, Oliver W., additional

Published
2015
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16. Dose-dense induction followed by autolous stern cell transplant (ASCT) as 1st line treatment in peripheral T-cell lymphomas (PTCL) -:A phase II study of the Nordic Lymphoma Group

Author

D'Amore, Francesco, Relander, Thomas, Lauritzsen, Grethe, Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Cavallin-Ståhl, Eva, Holte, Harald, Østerborg, Anders, Merup, Mats, Hansen, Mads, Telhaug, Ragnar, Erlandson, Martin, Kuittinen, Outi, Gadeberg, Ole Vestergaard, Delabie, Jan, Sundström, Christer, Ralfkiær, Elisabeth, Vornanen, Marine, and Jensen, Charlotte B.

Published
2006

18. Combination of two anti-CD5 monoclonal antibodies synergistically induces complement-dependent cytotoxicity of chronic lymphocytic leukaemia cells

Author

Klitgaard, Josephine L, Koefoed, Klaus, Geisler, Christian, Gadeberg, Ole Vestergaard, Frank, David A, Petersen, Jørgen, Jurlander, Jesper, Pedersen, Mikkel Winther, Klitgaard, Josephine L, Koefoed, Klaus, Geisler, Christian, Gadeberg, Ole Vestergaard, Frank, David A, Petersen, Jørgen, Jurlander, Jesper, and Pedersen, Mikkel Winther

Published
2013

19. Up-Front Autologous Stem-Cell Transplantation in Peripheral T-Cell Lymphoma : NLG-T-01

Author

d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete F., Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Holte, Harald, Osterborg, Anders, Merup, Mats, Brown, Peter, Kuittinen, Outi, Erlanson, Martin, Ostenstad, Bjorn, Fagerli, Unn-Merete, Gadeberg, Ole V., Sundström, Christer, Delabie, Jan, Ralfkiaer, Elisabeth, Vornanen, Martine, Toldbod, Helle E., d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete F., Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Holte, Harald, Osterborg, Anders, Merup, Mats, Brown, Peter, Kuittinen, Outi, Erlanson, Martin, Ostenstad, Bjorn, Fagerli, Unn-Merete, Gadeberg, Ole V., Sundström, Christer, Delabie, Jan, Ralfkiaer, Elisabeth, Vornanen, Martine, and Toldbod, Helle E.

Abstract

Purpose Systemic peripheral T-cell lymphomas (PTCLs) respond poorly to conventional therapy. To evaluate the efficacy of a dose-dense approach consolidated by up-front high-dose chemotherapy (HDT) and autologous stem-cell transplantation (ASCT) in PTCL, the Nordic Lymphoma Group (NLG) conducted a large prospective phase II study in untreated systemic PTCL. This is the final report, with a 5-year median follow-up, of the NLG-T-01 study. Patients and Methods Treatment-naive patients with PTCL age 18 to 67 years (median, 57 years) were included. Anaplastic lymphoma kinase (ALK) -positive anaplastic large-cell lymphoma (ALCL) was excluded. An induction regimen of six cycles of biweekly CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone) was administered (in patients age > 60 years, etoposide was omitted). If in complete or partial remission, patients proceeded to consolidation with HDT/ASCT. Results Of 166 enrolled patients, 160 had histopathologically confirmed PTCL. The majority presented with advanced-stage disease, B symptoms, and elevated serum lactate dehydrogenase. A total of 115 underwent HDT/ASCT, with 90 in complete remission at 3 months post-transplantation. Early failures occurred in 26%. Treatment-related mortality was 4%. At 60.5 months of median follow-up, 83 patients were alive. Consolidated 5-year overall and progression-free survival (PFS) were 51% (95% CI, 43% to 59%) and 44% (95% CI, 36% to 52%), respectively. Best results were obtained in ALK-negative ALCL. Conclusion Dose-dense induction followed by HDT/ASCT was well tolerated and led to long-term PFS in 44% of treatment-naive patients with PTCL. This represents an encouraging outcome, particularly considering the high median age and adverse risk profile of the study population. Therefore, dose-dense induction and HDT/ASCT are a rational up-front strategy in transplantation-eligible patients with PTCL. J Clin Oncol 30: 3093-3099. (C) 2012 by American Society of Clinical

Published
2012
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20. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma:NLG-T-01

Author

d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete F, Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Holte, Harald, Österborg, Anders, Merup, Mats, Brown, Peter, Kuittinen, Outi, Erlanson, Martin, Østenstad, Bjørn, Fagerli, Unn-Merete, Gadeberg, Ole Vestergaard, Sundström, Christer, Delabie, Jan, Ralfkiaer, Elisabeth, Vornanen, Martine, Toldbod, Helle, d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete F, Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Holte, Harald, Österborg, Anders, Merup, Mats, Brown, Peter, Kuittinen, Outi, Erlanson, Martin, Østenstad, Bjørn, Fagerli, Unn-Merete, Gadeberg, Ole Vestergaard, Sundström, Christer, Delabie, Jan, Ralfkiaer, Elisabeth, Vornanen, Martine, and Toldbod, Helle

Abstract

Systemic peripheral T-cell lymphomas (PTCLs) respond poorly to conventional therapy. To evaluate the efficacy of a dose-dense approach consolidated by up-front high-dose chemotherapy (HDT) and autologous stem-cell transplantation (ASCT) in PTCL, the Nordic Lymphoma Group (NLG) conducted a large prospective phase II study in untreated systemic PTCL. This is the final report, with a 5-year median follow-up, of the NLG-T-01 study.

Published
2012

21. High-dose chemotherapy and autologuos stem cell transplantation in previously untreated peripheral T-Cell Lymphoma : Final analysis of a large prospective multicenter study (NLG-T-01)

Author

d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete F., Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Holte, Harald Jr., Osterborg, Anders, Merup, Mats, Brown, Peter de Nully, Kuittinen, Outi, Erlanson, Martin, Ostenstad, Bjorn, Fagerli, Unn-Merete, Gadeberg, Ole, Sundstrom, Christer, Delabie, Jan, Rafkiaer, Elisabeth, Vornanen, Martine, Toldbod, Helle, d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete F., Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Holte, Harald Jr., Osterborg, Anders, Merup, Mats, Brown, Peter de Nully, Kuittinen, Outi, Erlanson, Martin, Ostenstad, Bjorn, Fagerli, Unn-Merete, Gadeberg, Ole, Sundstrom, Christer, Delabie, Jan, Rafkiaer, Elisabeth, Vornanen, Martine, and Toldbod, Helle

Published
2011

22. Cigarette smoking and risk of non-Hodgkin's lymphoma : a population-based case-control study

Author

Schöllkopf, Claudia, Smedby, Karin Ekström, Hjalgrim, Henrik, Rostgaard, Klaus, Gadeberg, Ole, Roos, Göran, Porwit-Macdonald, Anna, Glimelius, Bengt, Adami, Hans-Olov, Melbye, Mads, Schöllkopf, Claudia, Smedby, Karin Ekström, Hjalgrim, Henrik, Rostgaard, Klaus, Gadeberg, Ole, Roos, Göran, Porwit-Macdonald, Anna, Glimelius, Bengt, Adami, Hans-Olov, and Melbye, Mads

Abstract

BACKGROUND: Epidemiologic evidence of an association between tobacco smoking and non-Hodgkin's lymphoma has been conflicting. This may reflect that non-Hodgkin's lymphoma comprises several distinct disease entities with different etiologies, as some studies have indicated an association between smoking and follicular lymphoma. OBJECTIVE: To investigate the association between cigarette smoking and non-Hodgkin's lymphoma risk, overall and by subtype. METHODS: As part of a nationwide Danish-Swedish population-based case-control study, we interviewed 3,055 incident non-Hodgkin's lymphoma patients and 3,187 population controls. All lymphomas were uniformly classified according to the WHO classification. We used unconditional logistic regression to estimate adjusted odds ratios (OR) and 95% confidence intervals (95% CI) for the association between cigarette smoking and risk of non-Hodgkin's lymphoma. RESULTS: Cigarette smoking was not associated with the risk of non-Hodgkin's lymphoma overall (OR, 0.97; 95% CI, 0.87-1.08) nor with the major subgroups such as diffuse large B-cell lymphoma (OR, 0.94; 95% CI, 0.79-1.10), chronic lymphocytic leukemia (OR, 0.86; 95% CI, 0.72-1.02), or follicular lymphoma (OR, 1.03; 95% CI, 0.85-1.24). Female smokers were at a marginally increased risk of follicular lymphoma (OR, 1.41; 95% CI, 1.04-1.92). Men who had ever smoked had a significantly increased risk of T-cell lymphoma (OR, 1.67; 95% CI, 1.11-2.51). No dose-response association with cigarette smoking could be established for any lymphoma subgroup. CONCLUSION: We found little evidence of an association between cigarette smoking and non-Hodgkin's lymphoma risk overall. Although increased risks of follicular lymphoma in female smokers and of T-cell lymphoma in male smokers were suggested, no dose-response relationship was observed, leaving limited support for causality.

Published
2005
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23. Cigarette smoking and risk of non-Hodgkin's lymphoma--a population-based case-control study.

Author

Schällkopf, Claudia, Smedby, Karin Ekström, Hjalgrim, Henrik, Rostgaard, Klaus, Gadeberg, Ole, Roos, Göran, Porwit-Macdonald, Anna, Glimelius, Bengt, Adami, Hans-Olov, Melbye, Mads, Schällkopf, Claudia, Smedby, Karin Ekström, Hjalgrim, Henrik, Rostgaard, Klaus, Gadeberg, Ole, Roos, Göran, Porwit-Macdonald, Anna, Glimelius, Bengt, Adami, Hans-Olov, and Melbye, Mads

Published
2005

24. A New Simplified Prognostic Index with Age Cut-off of 70 Years for Patients with Diffuse Large B-Cell Lymphoma. A Population-Based Analysis From the Danish Lymphoma Registry, LYFO

Author

Gang, Anne Ortved, primary, Pedersen, Michael, additional, d'Amore, Francesco, additional, Møller-Pedersen, Lars, additional, Pedersen, Bo Amdi, additional, Jensen, Paw, additional, Pedersen, Bjarne Bach, additional, Møller, Michael B., additional, Gadeberg, Ole, additional, Ingeberg, Steen, additional, mourits-Andersen, Torben, additional, Pulczynski, Stanislaw, additional, Klausen, Tobias Wirenfeldt, additional, and De Nully Brown, Peter, additional

Published
2012
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25. Ofatumumab (OFA) in Combination with CHOP for Previously Untreated Follicular Lymphoma: Follow-up Results

Author

Czuczman, Myron S., primary, Hess, Georg, additional, Gadeberg, Ole, additional, Pedersen, Lars Moeller, additional, Hansen, Per, additional, Belada, David, additional, Gregory, Stephanie A., additional, Pohlman, Brad, additional, Mayer, Jiri, additional, Pytlik, Robert, additional, Trumper, Lorenz, additional, Viardot, Andreas, additional, Gupta, Ira V., additional, Lin, Thomas S., additional, Winter, Paul, additional, Goldstein, Nancy, additional, Jewell, Roxanne C., additional, and Lisby, Steen, additional

Published
2012
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26. Immunohistochemical Double-Hit Score Is a Strong Predictor of Outcome in Patients With Diffuse Large B-Cell Lymphoma Treated With Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone

Author

Green, Tina Marie, primary, Young, Ken H., additional, Visco, Carlo, additional, Xu-Monette, Zijun Y., additional, Orazi, Attilio, additional, Go, Ronald S., additional, Nielsen, Ole, additional, Gadeberg, Ole V., additional, Mourits-Andersen, Torben, additional, Frederiksen, Mikael, additional, Pedersen, Lars Møller, additional, and Møller, Michael Boe, additional

Published
2012
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27. Up-Front Autologous Stem-Cell Transplantation in Peripheral T-Cell Lymphoma: NLG-T-01

Author

d'Amore, Francesco, primary, Relander, Thomas, additional, Lauritzsen, Grete F., additional, Jantunen, Esa, additional, Hagberg, Hans, additional, Anderson, Harald, additional, Holte, Harald, additional, Österborg, Anders, additional, Merup, Mats, additional, Brown, Peter, additional, Kuittinen, Outi, additional, Erlanson, Martin, additional, Østenstad, Bjørn, additional, Fagerli, Unn-Merete, additional, Gadeberg, Ole V., additional, Sundström, Christer, additional, Delabie, Jan, additional, Ralfkiaer, Elisabeth, additional, Vornanen, Martine, additional, and Toldbod, Helle E., additional

Published
2012
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28. High-Dose Chemotherapy and Autologuos Stem Cell Transplantation in Previously Untreated Peripheral T-Cell Lymphoma - Final Analysis of a Large Prospective Multicenter Study (NLG-T-01)

Author

d'Amore, Francesco, primary, Relander, Thomas, additional, Lauritzsen, Grete F., additional, Jantunen, Esa, additional, Hagberg, Hans, additional, Anderson, Harald, additional, Holte, Harald, additional, Österborg, Anders, additional, Merup, Mats, additional, de Nully Brown, Peter, additional, Kuittinen, Outi, additional, Erlanson, Martin, additional, Østenstad, Bjørn, additional, Fagerli, Unn-Merete, additional, Gadeberg, Ole, additional, Sundström, Christer, additional, Delabie, Jan, additional, Ralfkiaer, Elisabeth, additional, Vornanen, Martine, additional, and Toldbod, Helle, additional

Published
2011
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29. Favorable Outcome In ALK-Negative Anaplastic Large-Cell Lymphoma Following Intensive Induction Chemotherapy and Autologous Stem Cell Transplantation (ASCT): a Prospective Study by the Nordic Lymphoma Group (NLG-T-01)

Author

Relander, Thomas, primary, Lauritzsen, Grete Fossum, additional, Jantunen, Esa, additional, Hagberg, Hans, additional, Anderson, Harald, additional, Cavallin-Ståhl, Eva, additional, Holte, Harald, additional, Østerborg, Anders, additional, Merup, Mats, additional, Brown, Peter De Nully, additional, Østenstad, Bj∅rn, additional, Kuittinen, Outi, additional, Erlanson, Martin, additional, Fagerli, Unn-Merete, additional, Gadeberg, Ole, additional, Sundstrom, Christer, additional, Delabie, Jan, additional, Ralfkiaer, Elisabeth, additional, Vornanen, Martine, additional, and d’Amore, Francesco, additional

Published
2010
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30. Intensive Induction Chemotherapy Followed by Autologous Stem Cell Transplantation (ASCT) In Patients with Enteropathy-Associated T-Cell Lymphoma: a Prospective Study by the Nordic Lymphoma Group (NLG-T-01)

Author

Jantunen, Esa, primary, Relander, Thomas, additional, Lauritzsen, Grete Fossum, additional, Hagberg, Hans, additional, Anderson, Harald, additional, Cavallin-Ståhl, Eva, additional, Holte, Harald, additional, Østerborg, Anders, additional, Merup, Mats, additional, Brown, Peter De Nully, additional, Kuittinen, Outi, additional, Erlanson, Martin, additional, Østenstad, Bj∅rn, additional, Fagerli, Unn-Merete, additional, Gadeberg, Ole, additional, Sundstrom, Christer, additional, Delabie, Jan, additional, Ralfkiaer, Elisabeth, additional, Vornanen, Martine, additional, and d’Amore, Francesco, additional

Published
2010
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32. Epidemiological and Clinico-Pathological Features of Systemic Peripheral T-Cell Lymphomas (PTCL): A Population-Based Analysis from the Danish Lymphoma Registry LYFO

Author

d’Amore, Francesco, primary, de Nully Brown, Peter, additional, Pedersen, Lars Moeller, additional, Bukh, Anne, additional, Hansen, Per Boye, additional, Pedersen, Bjarne Bach, additional, Gadeberg, Ole, additional, Pedersen, Michael, additional, Ingeberg, Steen, additional, Pulczynski, Stanislaw, additional, Andersen, Torben Mourits, additional, and Moeller, Michael, additional

Published
2008
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33. Dose-Dense Induction Followed by Autologous Stem Cell Transplant (ASCT) as 1st Line Treatment in Peripheral T-Cell Lymphomas (PTCL) - A Phase II Study of the Nordic Lymphoma Group (NLG).

Author

d’Amore, Francesco, primary, Relander, Thomas, primary, Lauritzsen, Grete, primary, Jantunen, Esa, primary, Hagberg, Hans, primary, Anderson, Harald, primary, Cavallin-Ståhl, Eva, primary, Holte, Harald, primary, Østerborg, Anders, primary, Merup, Mats, primary, Hansen, Mads, primary, Telhaug, Ragnar, primary, Erlanson, Martin, primary, Kuittinen, Outi, primary, Gadeberg, Ole, primary, Delabie, Jan, primary, Sundström, Christer, primary, Ralfkiær, Elisabeth, primary, Vornanen, Martine, primary, and Jensen, Charlotte B., primary

Published
2006
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42. Isolation of human peripheral blood monocytes: A comparative methodological study

Author

Gadeberg, Ole V., Rhodes, Joan M., and Larsen, Severin Olesen

Abstract

Monocytes were isloted from 8.0 ml of peripheral human blood by 4 different procedures: (I) Dextran sedimentation followed by bovine serum albumin buoyant density centrifugation (BSA-BDC) of supernatant cells. (II) Metrizoate/polysucrose buoyant density centrifugation (M/P-BDC). (III) M/P-BDC followed by formation of rosettes by interface cells with sheep red blood cells (SRBC) treated with 2-aminoethylisothiouronium bromide (AET) and a second M/P-BDC. (IV) M/P-BDC with subsequent incubation of interface cells on plastic petri dishes and removal of adherent cells by a rubber policeman. The degree of purification of monocytes was 28, 21, 65 and 24% and the monocyte yield amounted to 51, 97, 58 and 9% after procedures I, II, III and IV, respectively. Cell viability was 99–100% after procedures I II annd III and 70% after procedure IV. Contamination with granulocytes was less than 2% for all procedures, while procedure III resulted in heavy contamination of isolated cells with SRBC. Monocytes isolated by procedures III and IV showed reduced ingestion of latex compared with cells from procedures I and II. Procedure II was by far the most rapid and simple technique of the 4 and resulted in the best preservation of the esterase-staining properties of monocytes. There was a marked day-to-day and person-to-person variation of peripheral and monocyte counts. The numbers of monocytes in blood smears were found to be highest when cells were identified by staining for non-specific esterase. Morphological identification after staining with Wright's stain yielded on the average only 85% of the number found using the enzyme stain. These two methods for identification of monocytes showed excellent agreement when cells were counted after cytocentrifugation.

Published
1979
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43. Role of alpha-Hemolysin for the in vitro Phagocytosis and intracellular killing of Escherichia coli

Author

Hacker, Jörg, Gadeberg, Ole V., and Orskov, Ida

Subjects
Escherichia coli, ddc:610
Abstract

The_role of a-hemolysin for the elimination of Eschericbia coli by phagocyres in vitro was investigated using sets of isogenic strains which included wild-type a -hemolyric srrains, derived strains with a reduced production of a-hemolysin and derived nonhemolytic strains. Phagocyrosis and intracellular killing of the bacteria by human blood granulocytes or monocytes were measured using growth inhibition rechniques. a-hemolytic strains were phagocytosed and killed ro a Jesser extent than isogenic strains with a reduced production of o:hemoJysin and isogenic nonhemolytic strains. The results obrained with granulocyres were similar to rhose obtained with monocyres although the elimination of bacteria by monocytes was less than that by granulocytes. These resulcs strongJy suggest that production of ahemolysin is a means by which E. coli counteracrs the activity of phagocytes by injuring these cells with the toxin., Die Rolle von a-Hämolysin bei der in vitro·Eliminierung von Escherichia coli durch Phagozyten wurde unter Verwendung isogener Stämme einschließlich von a-hämolysierenden Wildstämmen, davon abstammenden Stämmen mit reduzierter a-Hämolysin-Bildung und davon abstammenden nicht hämolysierenden Stämmen untersuche. Phagozytose und intrazelluläre Abtötung der Bakterien durch Granulozyten oder Monozyten im menschlieben Blut wurden u.nter Verwendung von Wachstums-Hemmtechniken gemessen. o:-hämolysierende Stämme wurden in geringerem Maße als isogene Stämme mit einer geringeren Hämolysin-Bildung und isogene nicht hämolysierende Stämme pbago:z.ytiert und ;~bgetötet. Die mit Granulozyten erzielten Ergebnisse waren den bei Monozyten ähnlich, obwohl die Bakterienelimination durch Monozyten geringer war als durch Granulozyten. Diese Ergebnisse deuten stark darauf hin, daß die Bildung von a-Hämolysin ein Mine) ist, mit dem E. coli der Aktivität der Phagozyten durch Schädigung dieser Zellen mit dem Toxin entgegenwirkt.

Published
1989

47. Dose-Dense Induction Followed by Autologous Stem Cell Transplant (ASCT) as 1st Line Treatment in Peripheral T-Cell Lymphomas (PTCL) - A Phase II Study of the Nordic Lymphoma Group (NLG).

Author

d'Amore, Francesco, Relander, Thomas, Lauritzsen, Grete, Jantunen, Esa, Hagberg, Hans, Anderson, Harald, Cavallin-Ståhl, Eva, Holte, Harald, Østerborg, Anders, Merup, Mats, Hansen, Mads, Telhaug, Ragnar, Erlanson, Martin, Kuittinen, Outi, Gadeberg, Ole, Delabie, Jan, Sundström, Christer, Ralfkiær, Elisabeth, Vornanen, Martine, and Jensen, Charlotte B.

Abstract

Systemic PTCL, with the exception of alk-positive anaplastic large cell lymphoma (ALCL), have a poor prognosis. ASCT has been shown to have a favourable impact on relapsed PTCL. Therefore, the NLG designed a prospective multicenter phase II study to evaluate the impact of a dose-intensified induction schedule (6 courses of two-weekly CHOEP) consolidated in 1st PR/CR with high-dose therapy (BEAM) followed by ASCT in previously untreated systemic PTCL. This is the largest prospective PTCL-specific trial published so far. Newly diagnosed non-primary cutaneous PTCL cases aged 18–67 yrs were eligible for enrollment. Cases of alk-positive ALCL were excluded. From Oct 2001 to Feb 2006, 99 histologically confirmed PTCL cases were included in the study: PTCL unspecified (n=41), alk-neg ALCL (n=24), AILT (n=15), enteropathy-type (n=12), panniculitis-like (n=3), T/NK nasal-type (n=2), hepatosplenic (n=2). The M/F ratio was 1.8 and the median age 55 yrs (range 20–67 yrs). Although almost 2/3 of the cases presented with advanced-stage disease (62%), B-symptoms (61%) and/or elevated s-LDH (63%), the majority of them (65%) had a good performance score (WHO 0–1) at diagnosis. Of the 77 patients, where information was available for all 6 induction courses, 68 (88%) were in CR (31) or PR (37) after the 3rd and 66 (86%) after the 6th course. A total of 58 patients (75%) went through ASCT indicating that at least a fourth of this younger patient cohort has a primary refractory disease and fails therapy before reaching the transplant. Treatment-related toxicity after both induction and high-dose treatment was manageable. Of the 58 transplanted patients, 50 (86%) were still in remission at re-evaluation short after transplant. In 39 patients follow-up data one year post-transplant were available: 30 are still in CR and 9 have relapsed, suggesting that post-transplant relapses probably account for another 25% of the original patient cohort. In conclusion, the present data indicate that a time- and dose-intensified schedule is feasible and effective in previously untreated systemic PTCL. Continuous remissions are not uncommon, but a longer follow-up is needed to further characterize long-term remission rates and evaluate their impact on time-to-treatment failure and overall survival.

Published
2006
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48. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study

Author

Jonathan W. Friedberg, Michael Crump, Ole V. Gadeberg, Oliver W. Press, Pier Luigi Zinzani, Akiko Chai, Laurie H. Sehn, Swaminathan Padmanabhan Iyer, Tara Baetz, Günter Fingerle-Rowson, Gianluca Gaidano, M. Dolores Caballero, Andre Goy, Andrew D. Zelenetz, Rena Buckstein, Giovanni Martinelli, Deniz Sahin, Luis Fayad, Branimir Jakšić, Fritz Offner, Sehn, Laurie H, Goy, Andre, Offner, Fritz C, Martinelli, Giovanni, Caballero, M Dolore, Gadeberg, Ole, Baetz, Tara, Zelenetz, Andrew D, Gaidano, Gianluca, Fayad, Luis E, Buckstein, Rena, Friedberg, Jonathan W, Crump, Michael, Jaksic, Branimir, Zinzani, Pier Luigi, Padmanabhan Iyer, Swaminathan, Sahin, Deniz, Chai, Akiko, Fingerle-Rowson, Günter, and Press, Oliver W

Subjects
Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Lymphoma, B-Cell, Chronic lymphocytic leukemia, Follicular lymphoma, Lymphoma, B-Cell/drug therapy, Antineoplastic Agents, Antibodies, Monoclonal, Humanized, Disease-Free Survival, Drug Administration Schedule, Antigens, CD20/biosynthesis, Rituximab/administration & dosage, chemistry.chemical_compound, Maintenance therapy, Obinutuzumab, immune system diseases, Internal medicine, hemic and lymphatic diseases, follicular lymphoma, Obinutuzumab, GA101, anti-CD20 monoclonal antibody, non-Hodgkin lymphoma, relapsed/refractory non-Hodgkin lymphoma, obinutuzumab with rituximab, relapsed indolent lymphoma, medicine, Humans, Prospective Studies, Infusions, Intravenous, Aged, CD20, Aged, 80 and over, biology, business.industry, CHRONIC LYMPHOCYTIC-LEUKEMIA MONOCLONAL-ANTIBODY THERAPY ADVANCED FOLLICULAR LYMPHOMA PROGRESSION-FREE SURVIVAL LOW-GRADE SIGNIFICANTLY INCREASES MAINTENANCE TREATMENT ANTI-CD20 ANTIBODY PROLONGS SURVIVAL CYCLOPHOSPHAMIDE, ORIGINAL REPORTS, Middle Aged, medicine.disease, Antigens, CD20, Lymphoma, Surgery, Antineoplastic Agents/administration & dosage, chemistry, biology.protein, B-Cell Non-Hodgkin Lymphoma, Rituximab, Female, business, medicine.drug, Antibodies, Monoclonal, Humanized/administration & dosage
Abstract

Purpose Obinutuzumab (GA101), a novel glycoengineered type II anti-CD20 monoclonal antibody, demonstrated responses in single-arm studies of patients with relapsed/refractory non-Hodgkin lymphoma. This is the first prospective, randomized study comparing safety and efficacy of obinutuzumab with rituximab in relapsed indolent lymphoma. The primary end point of this study was the overall response rate (ORR) in patients with follicular lymphoma after induction and safety in patients with indolent lymphoma. Patients and Methods A total of 175 patients with relapsed CD20+ indolent lymphoma requiring therapy and with previous response to a rituximab-containing regimen were randomly assigned (1:1) to four once-per-week infusions of either obinutuzumab (1,000 mg) or rituximab (375 mg/m2). Patients without evidence of disease progression after induction therapy received obinutuzumab or rituximab maintenance therapy every 2 months for up to 2 years. Results Among patients with follicular lymphoma (n = 149), ORR seemed higher for obinutuzumab than rituximab (44.6% v 33.3%; P = .08). This observation was also demonstrated by a blinded independent review panel that measured a higher ORR for obinutuzumab (44.6% v 26.7%; P = .01). However, this difference did not translate into an improvement in progression-free survival. No new safety signals were observed for obinutuzumab, and the incidence of adverse events was balanced between arms, with the exception of infusion-related reactions and cough, which were higher in the obinutuzumab arm. Conclusion Obinutuzumab demonstrated a higher ORR without appreciable differences in safety compared with rituximab. However, the clinical benefit of obinutuzumab in this setting remains unclear and should be evaluated within phase III trials.

Published
2015
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