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2. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL: the HOVON-100 trial

Author

Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Daniëlle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie-Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurélie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., and Cornelissen, Jan J.

Published
2022
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4. Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: the HOVON-SAKK-132 trial

Author

Löwenberg, Bob, Pabst, Thomas, Maertens, Johan, Gradowska, Patrycja, Biemond, Bart J., Spertini, Olivier, Vellenga, Edo, Griskevicius, Laimonas, Tick, Lidwine W., Jongen-Lavrencic, Mojca, van Marwijk Kooy, Marinus, Vekemans, Marie-Christiane, van der Velden, Walter J.F.M., Beverloo, Berna, Michaux, Lucienne, Graux, Carlos, Deeren, Dries, de Weerdt, Okke, van Esser, Joost W.J., Bargetzi, Mario, Klein, Saskia K., Gadisseur, Alain, Westerweel, Peter E., Veelken, Hendrik, Gregor, Michael, Silzle, Tobias, van Lammeren-Venema, Daniëlle, Moors, Ine, Breems, Dimitri A., Hoogendoorn, Mels, Legdeur, Marie-Cecile J.C., Fischer, Thomas, Kuball, Juergen, Cornelissen, Jan, Porkka, Kimmo, Juliusson, Gunnar, Meyer, Peter, Höglund, Martin, Gjertsen, Bjorn T., Janssen, Jeroen J.W.M., Huls, Gerwin, Passweg, Jakob, Cloos, Jacqueline, Valk, Peter J.M., van Elssen, Catharina H.M.J., Manz, Markus G., Floisand, Yngvar, and Ossenkoppele, Gert J.

Published
2021
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5. Benefits and risks of clofarabine in adult acute lymphoblastic leukemia investigated in depth by multi-state modeling

Author

Hermans, Sjoerd J.F., van Norden, Yvette, Versluis, Jurjen, Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjan A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Daniëlle, van der Velden, Vincent H.J., de Wreede, Liesbeth C., Postmus, Douwe, Pignatti, Francesco, Cornelissen, Jan J., Hermans, Sjoerd J.F., van Norden, Yvette, Versluis, Jurjen, Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjan A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Daniëlle, van der Velden, Vincent H.J., de Wreede, Liesbeth C., Postmus, Douwe, Pignatti, Francesco, and Cornelissen, Jan J.

Abstract

Background: We recently reported results of the prospective, open-label HOVON-100 trial in 334 adult patients with acute lymphoblastic leukemia (ALL) randomized to first-line treatment with or without clofarabine (CLO). No improvement of event-free survival (EFS) was observed, while a higher proportion of patients receiving CLO obtained minimal residual disease (MRD) negativity. Aim: In order to investigate the effects of CLO in more depth, two multi-state models were developed to identify why CLO did not show a long-term survival benefit despite more MRD-negativity. Methods: The first model evaluated the effect of CLO on going off-protocol (not due to refractory disease/relapse, completion or death) as a proxy of severe treatment-related toxicity, while the second model evaluated the effect of CLO on obtaining MRD negativity. The subsequent impact of these intermediate events on death or relapsed/refractory disease was assessed in both models. Results: Overall, patients receiving CLO went off-protocol more frequently than control patients (35/168 [21%] vs. 18/166 [11%], p = 0.019; HR 2.00 [1.13–3.52], p = 0.02), especially during maintenance (13/44 [30%] vs. 6/56 [11%]; HR 2.85 [95%CI 1.08–7.50], p = 0.035). Going off-protocol was, however, not associated with more relapse or death. Patients in the CLO arm showed a trend towards an increased rate of MRD-negativity compared with control patients (HR MRD-negativity: 1.35 [0.95–1.91], p = 0.10), which did not translate into a significant survival benefit. Conclusion: We conclude that the intermediate states, i.e., going off-protocol and MRD-negativity, were affected by adding CLO, but these transitions were not associated with subsequent survival estimates, suggesting relatively modest antileukemic activity in ALL.

Published
2024

7. Predictors of the corrected count increment after platelet transfusion, a secondary analysis of the PACER randomized controlled trial

Author

van Baarle, Floor L.F., van de Weerdt, Emma K., van der Velden, Walter J.F.M., Ruiterkamp, Roelof A., Tuinman, Pieter R., Ypma, Paula F., van den Bergh, Walter M., Demandt, Astrid M.P., Kerver, Emile D., Jansen, A. J.Gerard, Westerweel, Peter E., Arbous, M. Sesmu, Determann, Rogier M., van Mook, Walther N.K.A., Koeman, Mirelle, Mäkelburg, Anja B.U., van Lienden, Krijn P., Vlaar, Alexander P.J., Biemond, Bart J., van Baarle, Floor L.F., van de Weerdt, Emma K., van der Velden, Walter J.F.M., Ruiterkamp, Roelof A., Tuinman, Pieter R., Ypma, Paula F., van den Bergh, Walter M., Demandt, Astrid M.P., Kerver, Emile D., Jansen, A. J.Gerard, Westerweel, Peter E., Arbous, M. Sesmu, Determann, Rogier M., van Mook, Walther N.K.A., Koeman, Mirelle, Mäkelburg, Anja B.U., van Lienden, Krijn P., Vlaar, Alexander P.J., and Biemond, Bart J.

Published
2023

10. The HOVON 100 Study in Adult Acute Lymphoblastic Leukemia Re-Analysed By Multi-State Modeling: Benefits and Risks of Clofarabine

Author

Hermans, Sjoerd J.F., primary, Norden, Yvette, additional, Versluis, Jurjen, additional, Rijneveld, Anita W., additional, De Weerdt, Okke, additional, Biemond, Bart J., additional, van de Loosdrecht, Arjan A., additional, Van der Wagen, Lotte E., additional, Bellido, Mar, additional, Van Gelder, Michel, additional, Van der Velden, Walter J.F.M., additional, Selleslag, Dominik, additional, van Lammeren, Danielle, additional, van der Velden, Vincent H.J., additional, de Wreede, Liesbeth C., additional, Postmus, Douwe, additional, Pignatti, Francesco, additional, and Cornelissen, Jan J., additional

Published
2022
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12. Association of Disparities in Known Minor Histocompatibility Antigens with Relapse-Free Survival and Graft-versus-Host Disease after Allogeneic Stem Cell Transplantation

Author

Hobo, Willemijn, Broen, Kelly, van der Velden, Walter J.F.M., Greupink-Draaisma, Annelies, Adisty, Niken, Wouters, Yannick, Kester, Michel, Fredrix, Hanny, Jansen, Joop H., van der Reijden, Bert, Falkenburg, J.H. Frederik, de Witte, Theo, Preijers, Frank, Schattenberg, Ton, Feuth, Ton, Blijlevens, Nicole M., Schaap, Nicolaas, and Dolstra, Harry

Published
2013
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13. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL:the HOVON-100 trial

Author

Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Danie€lle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurelie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., Cornelissen, Jan J., Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Danie€lle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurelie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., and Cornelissen, Jan J.

Abstract

Clofarabine (CLO) is a nucleoside analog with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase 3 study aimed to evaluate whether CLO added to induction and whether consolidation would improve outcome in adults with newly diagnosed ALL. Treatment of younger (18-40 years) patients consisted of a pediatric-inspired protocol, and for older patients (41-70 years), a semi-intensive protocol was used. Three hundred and forty patients were randomized. After a median follow-up of 70 months, 5-year event-free survival (EFS) was 50% and 53% for arm A and B (CLO arm). For patients #40 years, EFS was 58% vs 65% in arm A vs B, whereas in patients .40 years, EFS was 43% in both arms. Complete remission (CR) rate was 89% in both arms and similar in younger and older patients. Minimal residual disease (MRD) was assessed in 200 patients (60%). Fifty-four of 76 evaluable patients (71%) were MRD2 after consolidation 1 in arm A vs 75/81 (93%) in arm B (P 5 .001). Seventy (42%) patients proceeded to allogeneic hematopoietic stem cell transplantation in both arms. Five-year overall survival (OS) was similar in both arms: 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and nonrelapse mortality was 16% vs 17% after CR. CLO-treated patients experienced more serious adverse events, more infections, and more often went off protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity.

Published
2022

16. Anti-thymocyte globulin with CsA and MMF as GVHD prophylaxis in nonmyeloablative HLA-mismatched allogeneic HCT

Author

CTI De Witte, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, CTI Kuball, van der Velden, Walter J.F.M., Choi, Goda, de Witte, Moniek A., van der Meer, Arnold, de Haan, Anton F.J., Blijlevens, Nicole M.A., Huls, Gerwin, Kuball, Jürgen, van Dorp, Suzanne, CTI De Witte, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, CTI Kuball, van der Velden, Walter J.F.M., Choi, Goda, de Witte, Moniek A., van der Meer, Arnold, de Haan, Anton F.J., Blijlevens, Nicole M.A., Huls, Gerwin, Kuball, Jürgen, and van Dorp, Suzanne

Published
2021

17. Early stop polymorphism in human DECTIN-1 is associated with increased candida colonization in hematopoietic stem cell transplant recipients

Author

Plantinga, Theo S., van der Velden, Walter J.F.M., Ferwerda, Bart, van Spriel, Annemiek B., Adema, Gosse, Feuth, Ton, Donnelly, J. Peter, Brown, Gordon D., Kullberg, Bart-Jan, Blijlevens, Nicole M.A., and Netea, Mihai G.

Subjects
Genetic polymorphisms -- Research, Genetic polymorphisms -- Control, Candida -- Research, Candida -- Physiological aspects, Candidiasis -- Prevention, Hematopoietic stem cells -- Transplantation, Hematopoietic stem cells -- Usage, Hematopoietic stem cells -- Patient outcomes, Health, Health care industry
Published
2009

18. BCG Vaccination in Humans Elicits Trained Immunity via the Hematopoietic Progenitor Compartment

Author

Cirovic, Branko, primary, de Bree, L. Charlotte J., additional, Groh, Laszlo, additional, Blok, Bas A., additional, Chan, Joyce, additional, van der Velden, Walter J.F.M., additional, Bremmers, M.E.J., additional, van Crevel, Reinout, additional, Händler, Kristian, additional, Picelli, Simone, additional, Schulte-Schrepping, Jonas, additional, Klee, Kathrin, additional, Oosting, Marije, additional, Koeken, Valerie A.C.M., additional, van Ingen, Jakko, additional, Li, Yang, additional, Benn, Christine S., additional, Schultze, Joachim L., additional, Joosten, Leo A.B., additional, Curtis, Nigel, additional, Netea, Mihai G., additional, and Schlitzer, Andreas, additional

Published
2020
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21. Long-term follow-up of a trial comparing post-remission treatment with autologous or allogeneic bone marrow transplantation or intensive chemotherapy in younger acute myeloid leukemia patients

Author

Baron, Frédéric, primary, Efficace, Fabio, additional, Cannella, Laura, additional, Willemze, Roel, additional, Vignetti, Marco, additional, Muus, Petra, additional, Marie, Jean-Pierre, additional, Ferrero, Dario, additional, Fazi, Paola, additional, La Sala, Edoardo, additional, Bourhis, Jean-Henri, additional, Fabbiano, Francesco, additional, Bosi, Alberto, additional, Sborgia, Marco, additional, Martinelli, Giovanni, additional, Wittnebel, Sebastian, additional, Trisolini, Silvia, additional, Petti, Maria Concetta, additional, Halkes, Constantijn J.M., additional, van der Velden, Walter J.F.M., additional, de Witte, Theo, additional, Amadori, Sergio, additional, Zittoun, Robert A, additional, and Suciu, Stefan, additional

Published
2019
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22. Phase I/II Trial of a Combination of Anti-CD3/CD7 Immunotoxins for Steroid-Refractory Acute Graft-versus-Host Disease

Author

Groth, Christoph, primary, van Groningen, Lenneke F.J., additional, Matos, Tiago R., additional, Bremmers, Manita E., additional, Preijers, Frank W.M.B., additional, Dolstra, Harry, additional, Reicherts, Christian, additional, Schaap, Nicolaas P.M., additional, van Hooren, Eric H.G., additional, IntHout, Joanna, additional, Masereeuw, Rosalinde, additional, Netea, Mihai G., additional, Levine, John E., additional, Morales, George, additional, Ferrara, James L., additional, Blijlevens, Nicole M.A., additional, van Oosterhout, Ypke V.J.M., additional, Stelljes, Matthias, additional, and van der Velden, Walter J.F.M., additional

Published
2019
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24. Long-Term Follow-up of Patients with Corticosteroid-Refractory Graft-Versus-Host Disease Treated with Ruxolitinib

Author

Zeiser, Robert, primary, Burchert, Andreas, additional, Lengerke, Claudia, additional, Verbeek, Mareike, additional, Maas-Bauer, Kristina, additional, Metzelder, Stephan, additional, Spoerl, Silvia, additional, Ditschkowski, Markus, additional, Ecsedi, Matyas, additional, Sockel, Katja, additional, Ayuk, Francis, additional, Salem, Ajib, additional, Sicre de Fontbrune, Flore, additional, Na, Il-Kang, additional, Livius, Penter, additional, Holtick, Udo, additional, Wolf, Dominik, additional, Schuler, Esther, additional, Meyer, Everett, additional, Apostolova, Petya, additional, Bertz, Hartmut, additional, Marks, Reinhard, additional, Lübbert, Michael, additional, Wäsch, Ralph, additional, Scheid, Christof, additional, Stölzel, Friedrich, additional, Ordemann, Rainer, additional, Bug, Gesine, additional, Kobbe, Guido, additional, Shah, Omid, additional, Negrin, Robert S., additional, Brune, Mats, additional, Spyridonidis, Alexandros, additional, Schmitt-Graeff, Annette, additional, van der Velden, Walter J.F.M., additional, Huls, Gerwin, additional, Mielke, Stephan, additional, Grigoleit, Goetz Ulrich, additional, Kuball, Jurgen, additional, Flynn, Ryan P, additional, Ihorst, Gabriele, additional, Du, Jing, additional, Blazar, Bruce R., additional, Arnold, Renate, additional, Kröger, Nicolaus, additional, Passweg, Jakob R., additional, Halter, Joerg, additional, Socié, Gérard, additional, Beelen, Dietrich W., additional, Peschel, Christian, additional, Neubauer, Andreas, additional, Finke, Jürgen, additional, Duyster, Justus, additional, and von Bubnoff, Nikolas, additional

Published
2016
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25. Post-Remission Treatment with Autologous or Allogeneic Bone Marrow Transplantation or Intensive Chemotherapy in Younger AML Patients: Long-Term Follow-up Results of the EORTC/Gimema AML-8A Study

Author

Baron, Frederic, primary, Efficace, Fabio, additional, Cannella, Laura, additional, Mandelli, Franco, additional, Willemze, Roelof, additional, Muus, Petra, additional, Marie, Jean-Pierre, additional, Ferrero, Dario, additional, Dictus, Marlies, additional, Fazi, Paola, additional, La Sala, Edoardo, additional, Bourhis, Jean-Henri, additional, Fabbiano, Francesco, additional, Bosi, Alberto, additional, Sborgia, Marco, additional, Martinelli, Giovanni, additional, Bron, Dominique, additional, Petti, Maria C., additional, Halkes, Constantijn J.M., additional, van der Velden, Walter J.F.M., additional, Boccadoro, Mario, additional, Amadori, Sergio, additional, Zittoun, Robert A., additional, and Suciu, Stefan, additional

Published
2016
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27. Association of Disparities in Known Minor Histocompatibility Antigens with Relapse-Free Survival and Graft-Versus-Host-Disease Upon Allogeneic Stem Cell Transplantation,

Author

Hobo, Willemijn, primary, Broen, Kelly, additional, van der Velden, Walter J.F.M., additional, Greupink-Draaisma, Annelies, additional, Adisty, Niken, additional, Wouters, Yannick, additional, Kester, Michel G.D., additional, Fredrix, Hanny, additional, Jansen, Joop H., additional, van der Reijden, Bert A., additional, Falkenburg, J.H. Frederik, additional, de Witte, Theo, additional, Preijers, Frank W.M.B., additional, Schattenberg, Anton, additional, Feuth, Ton, additional, Blijlevens, Nicole N.A., additional, Schaap, Nicolaas, additional, and Dolstra, Harry, additional

Published
2011
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30. Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL: the HOVON-100 trial

Author

Rijneveld, Anita W., van der Holt, Bronno, de Weerdt, Okke, Biemond, Bart J., van de Loosdrecht, Arjen A., van der Wagen, Lotte E., Bellido, Mar, van Gelder, Michel, van der Velden, Walter J.F.M., Selleslag, Dominik, van Lammeren-Venema, Daniëlle, Halkes, Constantijn J.M., Fijnheer, Rob, Havelange, Violaine, van Sluis, Geerte L., Legdeur, Marie-Cecile, Deeren, Dries, Gadisseur, Alain, Sinnige, Harm A.M., Breems, Dimitri A., Jaspers, Aurélie, Legrand, Ollivier, Terpstra, Wim E., Boersma, Rinske S., Mazure, Dominiek, Triffet, Agnes, Tick, Lidwine W., Beel, Karolien, Maertens, Johan A., Beverloo, H. Berna, Bakkus, Marleen, Homburg, Christa H.E., de Haas, Valerie, van der Velden, Vincent H.J., and Cornelissen, Jan J.

Abstract

Clofarabine (CLO) is a nucleoside analogue with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase III study aimed to evaluate whether CLO added to induction and consolidation would improve outcome in adults with newly diagnosed ALL.Treatment for younger (18-40 years) patients consisted of a pediatric inspired protocol and for older patients (41-70 years) of a semi-intensive protocol was used. 340 patients were randomized. After a median follow up of 70 months,5-year EFS was 50% and 53% for arm A and B (CLO arm). For patients ≤40 years, EFS was 58% vs 65% in arm A vs B, while in patients >40 years EFS was 43% in both arms. CR rate was 89% in both arms and similar in younger and older patients.Minimal residual disease (MRD) was assessedin 200 patients (60%).Fifty-fourof 76evaluable patients(71%) were MRD negative after consolidation 1 in arm A vs 75/81 (93%) in arm B (p=0.001). Seventy (42%) patients proceeded to allogeneic hematopoietic stemcell transplantation in both arms. Five years OS was similar in both arms, 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and non-relapse mortality was 16% vs 17% after CR. CLO treated patients experienced more serious adverse events, moreinfections, and more often went off-protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD-negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity.The trial is registered at www.trialregister.nl as NTR2004.

Published
2021
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