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1,071 results on '"Röllig, Christoph"'

201. Secondary-type mutations do not impact outcome in NPM1-mutated acute myeloid leukemia – implications for the European leukemia net risk classification

Author

Eckardt, Jan-Niklas, Bill, Marius, Rausch, Christian, Metzeler, Klaus, Spiekermann, Karsten, Stasik, Sebastian, Sauer, Tim, Scholl, Sebastian, Hochhaus, Andreas, Crysandt, Martina, Brümmendorf, Tim H., Krug, Utz, Wörmann, Bernhard, Hiddemann, Wolfgang, Görlich, Dennis, Sauerland, Cristina, Steffen, Björn, Einsele, Hermann, Neubauer, Andreas, Burchert, Andreas, Schäfer-Eckart, Kerstin, Berdel, Wolfgang E., Schliemann, Christoph, Krause, Stefan W., Hänel, Mathias, Hanoun, Maher, Kaufmann, Martin, Fransecky, Lars, Braess, Jan, Ruhnke, Leo, Schetelig, Johannes, Middeke, Jan Moritz, Serve, Hubert, Baldus, Claudia D., Platzbecker, Uwe, Müller-Tidow, Carsten, Bornhäuser, Martin, Herold, Tobias, Thiede, Christian, and Röllig, Christoph

Published
2023
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202. Characteristics and outcome of patients with acute myeloid leukaemia and t(8;16)(p11;p13): results from an International Collaborative Study*

Author

Kayser, Sabine, primary, Hills, Robert K., additional, Langova, Ralitsa, additional, Kramer, Michael, additional, Guijarro, Francesca, additional, Sustkova, Zuzana, additional, Estey, Elihu H., additional, Shaw, Carole M., additional, Ráčil, Zdeněk, additional, Mayer, Jiri, additional, Zak, Pavel, additional, Baer, Maria R., additional, Brunner, Andrew M., additional, Szotkowski, Tomas, additional, Cetkovsky, Petr, additional, Grimwade, David, additional, Walter, Roland B., additional, Burnett, Alan K., additional, Ho, Anthony D., additional, Ehninger, Gerhard, additional, Müller‐Tidow, Carsten, additional, Platzbecker, Uwe, additional, Thiede, Christian, additional, Röllig, Christoph, additional, Schulz, Angela, additional, Warsow, Gregor, additional, Brors, Benedikt, additional, Esteve, Jordi, additional, Russell, Nigel H., additional, Schlenk, Richard F., additional, and Levis, Mark J., additional

Published
2021
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206. Clinical Outcomes in Patients with Relapsed/Refractory Acute Myeloid Leukemia Treated with Gilteritinib Who Received Prior Midostaurin or Sorafenib

Author

Perl, Alexander E., primary, Altman, Jessica K., additional, Hosono, Naoko, additional, Montesinos, Pau, additional, Podoltsev, Nikolai A., additional, Martinelli, Giovanni, additional, Smith, Catherine C., additional, Levis, Mark, additional, Röllig, Christoph, additional, Groß-Langenhoff, Marco, additional, Hasabou, Nahla, additional, Lu, Qiaoyang, additional, and Tiu, Ramon V., additional

Published
2020
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207. Prevalence of Inherited Predisposition Syndromes in Young Patients with Acute Myeloid Leukemia and Aberrant Karyotype

Author

Kirschner, Martin, primary, Rolles, Benjamin, additional, Crysandt, Martina, additional, Röllig, Christoph, additional, Stolzel, Friedrich, additional, Bornhäuser, Martin, additional, Müller-Tidow, Carsten, additional, Kricheldorf, Kim, additional, Vieri, Margherita, additional, Begemann, Matthias, additional, Maurer, Angela, additional, Panse, Jens, additional, Isfort, Susanne, additional, Wlodarski, Marcin, additional, Sahoo, Sushree Sangita, additional, Brümmendorf, Tim H, additional, Jost, Edgar, additional, and Beier, Fabian, additional

Published
2020
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208. Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With FLT3–Internal Tandem Duplication Mutation (SORMAIN)

Author

Burchert, Andreas, primary, Bug, Gesine, additional, Fritz, Lea V., additional, Finke, Jürgen, additional, Stelljes, Matthias, additional, Röllig, Christoph, additional, Wollmer, Ellen, additional, Wäsch, Ralph, additional, Bornhäuser, Martin, additional, Berg, Tobias, additional, Lang, Fabian, additional, Ehninger, Gerhard, additional, Serve, Hubert, additional, Zeiser, Robert, additional, Wagner, Eva-Maria, additional, Kröger, Nicolaus, additional, Wolschke, Christine, additional, Schleuning, Michael, additional, Götze, Katharina S., additional, Schmid, Christoph, additional, Crysandt, Martina, additional, Eßeling, Eva, additional, Wolf, Dominik, additional, Wang, Ying, additional, Böhm, Alexandra, additional, Thiede, Christian, additional, Haferlach, Torsten, additional, Michel, Christian, additional, Bethge, Wolfgang, additional, Wündisch, Thomas, additional, Brandts, Christian, additional, Harnisch, Susanne, additional, Wittenberg, Michael, additional, Hoeffkes, Heinz-Gert, additional, Rospleszcz, Susanne, additional, Burchardt, Alexander, additional, Neubauer, Andreas, additional, Brugger, Markus, additional, Strauch, Konstantin, additional, Schade-Brittinger, Carmen, additional, and Metzelder, Stephan K., additional

Published
2020
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209. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia

Author

Montesinos, Pau, primary, Beckermann, Benjamin M, additional, Catalani, Olivier, additional, Esteve, Jordi, additional, Gamel, Katia, additional, Konopleva, Marina Y, additional, Martinelli, Giovanni, additional, Monnet, Annabelle, additional, Papayannidis, Cristina, additional, Park, Aaron, additional, Récher, Christian, additional, Rodríguez-Veiga, Rebeca, additional, Röllig, Christoph, additional, Vey, Norbert, additional, Wei, Andrew H, additional, Yoon, Sung-Soo, additional, and Fenaux, Pierre, additional

Published
2020
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212. Additional file 1 of Prevention, recognition, and management of adverse events associated with gemtuzumab ozogamicin use in acute myeloid leukemia

Author

Cortes, Jorge E., Lima, Marcos De, Dombret, Hervé, Estey, Elihu H., Giralt, Sergio A., Montesinos, Pau, Röllig, Christoph, Venditti, Adriano, and Wang, Eunice S.

Subjects
hemic and lymphatic diseases
Abstract

Additional file 1. Prevention, recognition, and management of adverse events associated with gemtuzumab ozogamicin use in acute myeloid leukemia.

Published
2020
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213. Stellungnahme zur Nutzenbewertung des G-BA von Arzneimitteln für seltene Erkrankungen gemäß § 35a SGB V, veröffentlicht am 2. März 2020, Vorgangsnummer 2018-12-01-D-503, IQWiG Bericht Nr. 884

Author

Bullinger, Lars, Schlenk, Richard Friedrich, Wörmann, Bernhard, Neubauer, Andreas, Braess, Jan, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie, Deutschland. Gemeinsamer Bundesausschuss, Röllig, Christoph, and Charité-Universitätsmedizin Berlin

Subjects
Medizin und Gesundheit
Published
2020
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215. Stellungnahme zur Nutzenbewertung des G-BA von Arzneimitteln für seltene Erkrankungen gemäß § 35a SGB V, veröffentlicht am 1. Dezember 2020, Vorgangsnummer 2020-08-15-D-565, IQWiG Bericht Nr. 998

Author

Bullinger, Lars, Schlenk, Richard Friedrich, Wörmann, Bernhard, Heuser, Michael, Braess, Jan, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie, Deutschland. Gemeinsamer Bundesausschuss, Fiedler, Walter, Röllig, Christoph, and Charité-Universitätsmedizin Berlin

Subjects
Medizin und Gesundheit
Published
2020
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216. A Mathematical Model for Relapse Prediction in AML Patients Based on Continuing NPM1 Measurements

Author

Hoffmann, Helene, Glauche, Ingmar, Thiede, Christian, Bornhäuser, Martin, Kramer, Michael, Röllig, Christoph, and Roeder, Ingo

Subjects
AML, relapse prediction, hemic and lymphatic diseases, education, mathematical modelling, health care economics and organizations
Abstract

The sumitted Poster was presented on the International Symposium ACUTE LEUKEMIAS XVII 2019 in Munich. On the poster a mathematical model on the molecular dynamics of stem cells in Acute Myeloid Leukemia (AML) is used for estimating the time of molecular relapse in AML patients. If there are any remarks or questions, please don't hesitate to contact me: helene.hoffmann@tu-dresden.de

Published
2019
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217. Validation of the Revised Pretransplant Assessment of Mortality Score in Patients with Acute Myelogenous Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Author

Middeke, Jan M., Kollinger, Frederike, Baldauf, Henning, Stölzel, Friedrich, Wermke, Martin, von Bonin, Malte, Sockel, Katja, Link, Cornelia S., Teipel, Raphael, Röllig, Christoph, Thiede, Christian, Platzbecker, Uwe, Ehninger, Gerhard, Bornhäuser, Martin, and Schetelig, Johannes

Published
2018
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218. Idasanutlin plus cytarabine in relapsed or refractory acute myeloid leukemia: results of the MIRROS trial

Author

Konopleva, Marina Y., Röllig, Christoph, Cavenagh, Jamie, Deeren, Dries, Girshova, Larisa, Krauter, Jürgen, Martinelli, Giovanni, Montesinos, Pau, Schäfer, Jonas A., Ottmann, Oliver, Petrini, Mario, Pigneux, Arnaud, Rambaldi, Alessandro, Recher, Christian, Rodriguez-Veiga, Rebeca, Taussig, David, Vey, Norbert, Yoon, Sung-Soo, Ott, Marion, Muehlbauer, Susanne, Beckermann, Benjamin M., Catalani, Olivier, Genevray, Magali, Mundt, Kirsten, Jamois, Candice, Fenaux, Pierre, and Wei, Andrew H.

Abstract

The phase 3 MIRROS (MDM2 antagonist Idasanutlin in Relapsed or Refractory acute myeloid leukemia [AML] for Overall Survival) trial (NCT02545283) evaluated the efficacy and safety of the small-molecule MDM2 antagonist idasanutlin plus cytarabine in patients with relapsed/refractory (R/R) AML. Adults (n = 447) with R/R AML whose disease relapsed or was refractory after ≤2 prior induction regimens as initial treatment or following salvage chemotherapy regimen, with Eastern Cooperative Oncology Group performance status ≤2 were enrolled regardless of TP53 mutation status and randomly assigned 2:1 to idasanutlin 300 mg or placebo orally twice daily plus cytarabine 1 g/m2 IV on days 1 to 5 of 28-day cycles. At primary analysis (cutoff, November 2019), 436 patients were enrolled, including 355 in the TP53 wild-type intention-to-treat (TP53WT-ITT) population. The primary endpoint, overall survival in the TP53WT-ITT population, was not met (median, 8.3 vs 9.1 months with idasanutlin-cytarabine vs placebo-cytarabine; stratified hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.81-1.45; P = .58). The complete remission (CR) rate, a key secondary endpoint, was 20.3% vs 17.1% (odds ratio [OR], 1.23; 95% CI, 0.70-2.18). The overall response rate (ORR) was 38.8% vs 22.0% (OR, 2.25; 95% CI, 1.36-3.72). Common any-grade adverse events (≥10% incidence in any arm) were diarrhea (87.0% vs 32.9%), febrile neutropenia (52.8% vs 49.3%), and nausea (52.5% vs 31.5%). In summary, despite improved ORR, adding idasanutlin to cytarabine did not improve overall survival or CR rates in patients with R/R AML.

Published
2022
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219. Using stroma-anchoring cytokines to augment ADCC: a phase 1 trial of F16IL2 and BI 836858 for posttransplant AML relapse

Author

Berdel, Andrew F., Ruhnke, Leo, Angenendt, Linus, Wermke, Martin, Röllig, Christoph, Mikesch, Jan-Henrik, Scheller, Annika, Hemmerle, Teresa, Matasci, Mattia, Wethmar, Klaus, Kessler, Torsten, Gerwing, Mirjam, Hescheler, Daniel, Schäfers, Michael, Hartmann, Wolfgang, Altvater, Bianca, Rossig, Claudia, Bornhäuser, Martin, Lenz, Georg, Stelljes, Matthias, Rueter, Bjoern, Neri, Dario, Berdel, Wolfgang E., and Schliemann, Christoph

Abstract

Natural killer (NK) cells are key effectors in cancer immunosurveillance and posttransplant immunity, but deficiency of environmental signals and insufficient tumor recognition may limit their activity. We hypothesized that the antibody-mediated anchoring of interleukin-2 (IL-2) to a spliced isoform of the extracellular matrix (ECM) glycoprotein tenascin-C would potentiate NK-cell–mediated antibody-dependent cellular cytotoxicity against leukemic blasts. In this novel-novel combination, dose-escalation, phase 1 trial, we enrolled patients with posttransplant acute myeloid leukemia (AML) relapse to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary activity of the antibody-cytokine fusion F16IL2 (10 × 106 to 20 × 106 IU IV; days 1, 8, 15, and 22 of each 28-day cycle) in combination with the anti-CD33 antibody BI 836858 (10-40 mg IV, 2 days after each F16IL2 infusion). Among the 15 patients (median [range] age, 50 [20-68] years) treated across 4 dose levels (DLs), 6 (40%) had received 2 or 3 prior transplantations. The most frequent adverse events were pyrexia, chills, and infusion-related reactions, which were manageable, transient and of grade ≤2. One dose-limiting toxicity occurred at each of DLs 3 (pulmonary edema) and 4 (graft-versus-host disease). Three objective responses were observed among 7 patients treated at the 2 higher DLs, whereas no responses occurred at the 2 starting DLs. Combination therapy stimulated the expansion and activation of NK cells, including those expressing the FcγRIIIA/CD16 receptor. ECM-targeted IL-2 combined with anti-CD33 immunotherapy represents an innovative approach associated with acceptable safety and encouraging biologic and clinical activity in posttransplant AML relapse. This trial was registered at EudraCT as 2015-004763-37.

Published
2022
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220. Deep sequencing in CD34+ cells from peripheral blood enables sensitive detection of measurable residual disease in AML

Author

Stasik, Sebastian, Burkhard-Meier, Clara, Kramer, Michael, Middeke, Jan M., Oelschlaegel, Uta, Sockel, Katja, Ehninger, Gerhard, Serve, Hubert, Müller-Tidow, Carsten, Baldus, Claudia D., Röllig, Christoph, Bornhäuser, Martin, Platzbecker, Uwe, and Thiede, Christian

Abstract

Monitoring of measurable residual disease (MRD) in patients with acute myeloid leukemia (AML) is predictive of disease recurrence and may identify patients who benefit from treatment intensification. Current MRD techniques rely on multicolor flow cytometry or molecular methods, but are limited in applicability or sensitivity. We evaluated the feasibility of a novel approach for MRD detection in peripheral blood (PB), which combines immunomagnetic preenrichment and fluorescence-activated cell sorting (FACS) for isolation of CD34+ cells with error-reduced targeted next-generation sequencing (NGS). For clinical validation, we retrospectively analyzed 429 PB and 55 bone marrow (BM) samples of 40 patients with AML or high-risk MDS, with/without molecular relapse based on CD34+ donor chimerism (DC), in complete remission after allogeneic stem cell transplantation. Enrichment of CD34+ cells for NGS increased the detection of mutant alleles in PB ∼1000-fold (median variant allele frequency, 1.27% vs 0.0046% in unsorted PB; P < .0001). Although a strong correlation was observed for the parallel analysis of CD34+ PB cells with NGS and DC (r = 0.8601), the combination of FACS and NGS improved sensitivity for MRD detection in dilution experiments ∼10-fold to levels of 10−6. In both assays, MRD detection was superior using PB vs BM for CD34+ enrichment. Importantly, NGS on CD34+ PB cells enabled prediction of molecular relapse with high sensitivity (100%) and specificity (91%), and significantly earlier (median, 48 days; range, 0-281; P = .0011) than by CD34+ DC or NGS of unsorted PB, providing additional time for therapeutic intervention. Moreover, panel sequencing in CD34+ cells allowed for the early assessment of clonal trajectories in hematological complete remission.

Published
2022
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221. Deep sequencing in CD34+cells from peripheral blood enables sensitive detection of measurable residual disease in AML

Author

Stasik, Sebastian, Burkhard-Meier, Clara, Kramer, Michael, Middeke, Jan M., Oelschlaegel, Uta, Sockel, Katja, Ehninger, Gerhard, Serve, Hubert, Müller-Tidow, Carsten, Baldus, Claudia D., Röllig, Christoph, Bornhäuser, Martin, Platzbecker, Uwe, and Thiede, Christian

Abstract

Monitoring of measurable residual disease (MRD) in patients with acute myeloid leukemia (AML) is predictive of disease recurrence and may identify patients who benefit from treatment intensification. Current MRD techniques rely on multicolor flow cytometry or molecular methods, but are limited in applicability or sensitivity. We evaluated the feasibility of a novel approach for MRD detection in peripheral blood (PB), which combines immunomagnetic preenrichment and fluorescence-activated cell sorting (FACS) for isolation of CD34+cells with error-reduced targeted next-generation sequencing (NGS). For clinical validation, we retrospectively analyzed 429 PB and 55 bone marrow (BM) samples of 40 patients with AML or high-risk MDS, with/without molecular relapse based on CD34+donor chimerism (DC), in complete remission after allogeneic stem cell transplantation. Enrichment of CD34+cells for NGS increased the detection of mutant alleles in PB ∼1000-fold (median variant allele frequency, 1.27% vs 0.0046% in unsorted PB; P< .0001). Although a strong correlation was observed for the parallel analysis of CD34+PB cells with NGS and DC (r= 0.8601), the combination of FACS and NGS improved sensitivity for MRD detection in dilution experiments ∼10-fold to levels of 10−6. In both assays, MRD detection was superior using PB vs BM for CD34+enrichment. Importantly, NGS on CD34+PB cells enabled prediction of molecular relapse with high sensitivity (100%) and specificity (91%), and significantly earlier (median, 48 days; range, 0-281; P= .0011) than by CD34+DC or NGS of unsorted PB, providing additional time for therapeutic intervention. Moreover, panel sequencing in CD34+cells allowed for the early assessment of clonal trajectories in hematological complete remission.

Published
2022
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222. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Abstract

Elotuzumab plus lenalidomide and dexamethasone has shown improved progression-free and overall survival versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. We aimed to assess these regimens in patients with newly diagnosed multiple myeloma who are ineligible for haematopoietic stem-cell transplantation (HSCT).

Published
2022
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223. Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML.

Author

Jaramillo, Sonia, Krisam, Johannes, Le Cornet, Lucian, Kratzmann, Markus, Baumann, Lukas, Sauer, Tim, Crysandt, Martina, Rank, Andreas, Behringer, Dirk, Teichmann, Lino, Görner, Martin, Trappe, Ralf-Ulrich, Röllig, Christoph, Krause, Stefan, Hanoun, Maher, Hopfer, Olaf, Held, Gerhard, Buske, Sebastian, Fransecky, Lars, and Kayser, Sabine

Abstract

Background: Overall survival remains poor in older patients with acute myeloid leukemia (AML) with less than 10% being alive after 5 years. In recent studies, a significant improvement in event-free, relapse-free and overall survival was shown by adding gemtuzumab ozogamicin (GO), a humanized antibody-drug conjugate directed against CD33, to intensive induction therapy once or in a sequential dosing schedule. Glasdegib, the small-molecule inhibitor of smoothened (SMO), also showed improved overall survival in patients not eligible for intensive chemotherapy when combined with low-dose cytarabine compared to low-dose cytarabine alone. These findings warrant further investigations in the phase III GnG trial.Methods/design: This is a randomized phase III trial with measurable residual disease (MRD) after induction therapy and event-free survival (EFS) as primary endpoints. The two research questions are addressed in a 2 by 2 factorial design. Patients age 60 years and older are upfront randomized 1:1 in one of the two induction arms: GO administered to intensive induction therapy on days 1,4, and 7 versus GO administered once on day 1 (GO-147 versus GO-1), and double-blinded 1:1 in one of the subsequent treatment arms glasdegib vs. placebo as adjunct to consolidation therapy and as single-agent maintenance therapy for six months. Chemotherapy backbone for induction therapy consists of standard 7 + 3 schedule with cytarabine 200 mg/m2 continuously days 1 to 7, daunorubicin 60 mg/m2 days 1, 2, and 3 and high-dose cytarabine (1 g/m2, bi-daily, days 1, 2, and 3) for consolidation therapy. Addressing two primary endpoints, MRD-negativity after induction therapy and event-free survival (EFS), 252 evaluable patients are needed to reject each of the two null hypotheses at a two-sided significance level of 2.5% with a power of at least 85%.Ethics and Dissemination: Ethical approval and approvals from the local and federal competent authorities were granted. Trial results will be reported via peer-reviewed journals and presented at conferences and scientific meetings.Trial Status: Protocol version: 1st version 20.10.2020, no amendments yet. Study initiation on February 16, 2021. First patient was recruited on April 1st.Trial Registration: ClinicalTrials.gov NCT04093505 ; EudraCT 2019-003913-32. Registered on October 30, 2018. [ABSTRACT FROM AUTHOR]

Published
2021
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224. Real-world experience of CPX-351 as first-line treatment for patients with acute myeloid leukemia.

Author

Rautenberg, Christina, Stölzel, Friedrich, Röllig, Christoph, Stelljes, Matthias, Gaidzik, Verena, Lauseker, Michael, Kriege, Oliver, Verbeek, Mareike, Unglaub, Julia Marie, Thol, Felicitas, Krause, Stefan W., Hänel, Mathias, Neuerburg, Charlotte, Vucinic, Vladan, Jehn, Christian-Friedrich, Severmann, Julia, Wass, Maxi, Fransecky, Lars, Chemnitz, Jens, and Holtick, Udo

Subjects
ACUTE myeloid leukemia, HEMATOPOIETIC stem cell transplantation, OVERALL survival, SURVIVAL rate, TREATMENT effectiveness
Abstract

To investigate the efficacy and toxicities of CPX-351 outside a clinical trial, we analyzed 188 patients (median age 65 years, range 26–80) treated for therapy-related acute myeloid leukemia (t-AML, 29%) or AML with myelodysplasia-related changes (AML-MRC, 70%). Eighty-six percent received one, 14% two induction cycles, and 10% received consolidation (representing 22% of patients with CR/CRi) with CPX-351. Following induction, CR/CRi rate was 47% including 64% of patients with available information achieving measurable residual disease (MRD) negativity (<10−3) as measured by flow cytometry. After a median follow-up of 9.3 months, median overall survival (OS) was 21 months and 1-year OS rate 64%. In multivariate analysis, complex karyotype predicted lower response (p = 0.0001), while pretreatment with hypomethylating agents (p = 0.02) and adverse European LeukemiaNet 2017 genetic risk (p < 0.0001) were associated with lower OS. Allogeneic hematopoietic cell transplantation (allo-HCT) was performed in 116 patients (62%) resulting in promising outcome (median survival not reached, 1-year OS 73%), especially in MRD-negative patients (p = 0.048). With 69% of patients developing grade III/IV non-hematologic toxicity following induction and a day 30-mortality of 8% the safety profile was consistent with previous findings. These real-world data confirm CPX-351 as efficient treatment for these high-risk AML patients facilitating allo-HCT in many patients with promising outcome after transplantation. [ABSTRACT FROM AUTHOR]

Published
2021
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225. Allogeneic hematopoietic cell transplantation improves outcome of adults with t(6;9) acute myeloid leukemia: results from an international collaborative study

Author

Kayser, Sabine, Hills, Robert K., Luskin, Marlise R., Brunner, Andrew M., Terré, Christine, Westermann, Jörg, Menghrajani, Kamal, Shaw, Carole, Baer, Maria R., Elliott, Michelle A., Perl, Alexander E., Ráčil, Zdeněk, Mayer, Jiri, Zak, Pavel, Szotkowski, Tomas, de Botton, Stéphane, Grimwade, David, Mayer, Karin, Walter, Roland B., Krämer, Alwin, Burnett, Alan K., Ho, Anthony D., Platzbecker, Uwe, Thiede, Christian, Ehninger, Gerhard, Stone, Richard M., Röllig, Christoph, Tallman, Martin S., Estey, Elihu H., Müller-Tidow, Carsten, Russell, Nigel H., Schlenk, Richard F., and Levis, Mark J.

Subjects
Adult, Acute Myeloid Leukemia, Leukemia, Myeloid, Acute, hemic and lymphatic diseases, Remission Induction, Cytarabine, Hematopoietic Stem Cell Transplantation, Humans, Middle Aged, Disease-Free Survival, Article, Retrospective Studies
Abstract

Acute myeloid leukemia (AML) with t(6;9)(p22;q34) is a distinct entity accounting for 1-2% of AML cases. A substantial proportion of these patients have a concomitant FLT3-ITD. While outcomes are dismal with intensive chemotherapy, limited evidence suggests allogeneic hematopoietic cell transplantation (allo-HCT) may improve survival if performed early during first complete remission. We report on a cohort of 178 patients with t(6;9)(p22;q34) within an international, multicenter collaboration. Median age was 46 years (range: 16-76), AML was de novo in 88%, FLT3-ITD was present in 62%, and additional cytogenetic abnormalities in 21%. Complete remission was achieved in 81% (n=144), including 14 patients who received high-dose cytarabine after initial induction failure. With a median follow up of 5.43 years, estimated overall survival at five years was 38% (95%CI: 31-47%). Allo-HCT was performed in 117 (66%) patients, including 89 in first complete remission. Allo-HCT in first complete remission was associated with higher 5-year relapse-free and overall survival as compared to consolidation chemotherapy: 45% (95%CI: 35-59%) and 53% (95%CI: 42-66%) versus 7% (95%CI: 3-19%) and 23% (95%CI: 13-38%), respectively. For patients undergoing allo-HCT, there was no difference in overall survival rates at five years according to whether it was performed in first [53% (95%CI: 42-66%)], or second [58% (95%CI: 31-100%); n=10] complete remission or with active disease/relapse [54% (95%CI: 34-84%); n=18] (P=0.67). Neither FLT3-ITD nor additional chromosomal abnormalities impacted survival. In conclusion, outcomes of t(6;9)(p22;q34) AML are poor with chemotherapy, and can be substantially improved with allo-HCT.

Published
2019
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226. Stellungnahme zur Nutzenbewertung des G-BA von Arzneimitteln gemäß § 35a SGB V, veröffentlicht am 2. Januar 2019, Vorgangsnummer 2018-10-01-D-403, IQWiG Bericht Nr. 698

Author

Weisel, Katja, Wörmann, Bernhard, Deutsche Krebsgesellschaft. Arbeitsgemeinschaft Für Internistische Onkologie, Goldschmidt, Hartmut, Deutschland. Gemeinsamer Bundesausschuss, Scheid, Christof, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie. Arbeitsgemeinschaft Für Internistische Onkologie, Einsele, Hermann, Knop, Stefan, and Röllig, Christoph

Subjects
Medizin und Gesundheit
Published
2019
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230. The clinical mutatome of core binding factor leukemia

Author

Opatz, Sabrina, primary, Bamopoulos, Stefanos A., additional, Metzeler, Klaus H., additional, Herold, Tobias, additional, Ksienzyk, Bianka, additional, Bräundl, Kathrin, additional, Tschuri, Sebastian, additional, Vosberg, Sebastian, additional, Konstandin, Nikola P., additional, Wang, Christine, additional, Hartmann, Luise, additional, Graf, Alexander, additional, Krebs, Stefan, additional, Blum, Helmut, additional, Schneider, Stephanie, additional, Thiede, Christian, additional, Middeke, Jan Moritz, additional, Stölzel, Friedrich, additional, Röllig, Christoph, additional, Schetelig, Johannes, additional, Ehninger, Gerhard, additional, Krämer, Alwin, additional, Braess, Jan, additional, Görlich, Dennis, additional, Sauerland, Maria Cristina, additional, Berdel, Wolfgang E., additional, Wörmann, Bernhard J., additional, Hiddemann, Wolfgang, additional, Spiekermann, Karsten, additional, Bohlander, Stefan K., additional, and Greif, Philipp A., additional

Published
2020
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232. Time from Diagnosis to Treatment Does Not Affect Outcome in Intensively Treated Patients with Newly Diagnosed Acute Myeloid Leukemia

Author

Röllig, Christoph, primary, Kramer, Michael, primary, Schliemann, Christoph, primary, Mikesch, Jan-Henrik, primary, Steffen, Björn, primary, Krämer, Alwin, primary, Sauer, Tim, primary, Hänel, Mathias, primary, Herbst, Regina, primary, Schäfer-Eckart, Kerstin, primary, Noppeney, Richard, primary, Jost, Edgar, primary, Brümmendorf, Tim H, primary, Krause, Stefan W, primary, Kunzmann, Volker, primary, Einsele, Hermann, primary, Scholl, Sebastian, primary, Hochhaus, Andreas, primary, Fransecky, Lars R., primary, Kaufmann, Martin, primary, Neubauer, Andreas, primary, Niemann, Dirk, primary, Schaich, Markus, primary, Frickhofen, Norbert, primary, Kiani, Alexander, primary, Heits, Frank, primary, Krümpelmann, Ulrich, primary, Kaiser, Ulrich, primary, Kullmer, Johannes, primary, Wass, Maxi, primary, Klein, Stefan, primary, Von Bonin, Malte, primary, Middeke, Jan Moritz, primary, Thiede, Christian, primary, Stoelzel, Friedrich, primary, Schetelig, Johannes, primary, Ehninger, Gerhard, primary, Baldus, Claudia D, primary, Müller-Tidow, Carsten, primary, Platzbecker, Uwe, primary, Serve, Hubert, primary, and Bornhäuser, Martin, primary

Published
2019
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233. Azacitidine for Pre-Emptive Treatment of Measurable-Residual Disease in MDS/AML Patients at High Risk of Hematological Relapse: Results of the Second Cohort of the RELAZA2 Trial

Author

Platzbecker, Uwe, primary, Middeke, Jan Moritz, primary, Sockel, Katja, primary, Herbst, Regina, primary, Fransecky, Lars R., primary, Wolf, Dominik, primary, Martin, Schumacher, primary, Krämer, Alwin, primary, Noppeney, Richard, primary, Novotny, Juergen, primary, Bug, Gesine, primary, Götze, Katharina, primary, Spiekermann, Karsten, primary, Stelljes, Matthias, primary, Groth, Christoph, primary, Subklewe, Marion, primary, Schubert, Antje, primary, Mütherig, Anke, primary, Bochtler, Tilmann, primary, Mende, Marika, primary, Kubasch, Anne Sophie, primary, Hänel, Mathias, primary, Dührsen, Ulrich, primary, Schetelig, Johannes, primary, Röllig, Christoph, primary, Baldus, Claudia D, primary, Ehninger, Gerhard, primary, Müller-Tidow, Carsten, primary, Serve, Hubert, primary, Kramer, Michael, primary, Bornhäuser, Martin, primary, and Thiede, Christian, primary

Published
2019
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234. Characteristics and Outcome of Patients with Core Binding Factor Acute Myeloid Leukemia and FLT3-ITD: Results from an International Collaboration

Author

Kayser, Sabine, primary, Elliott, Michelle A, additional, Luskin, Marlise, additional, Brunner, Andrew M., additional, Kramer, Michael, additional, Racil, Zdenek, additional, Sustkova, Zuzana, additional, Cetkovsky, Petr, additional, Novak, Jan, additional, Stoelzel, Friedrich, additional, Thiede, Christian, additional, Müller-Tidow, Carsten, additional, Platzbecker, Uwe, additional, Röllig, Christoph, additional, Schlenk, Richard F., additional, and Levis, Mark J., additional

Published
2019
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235. Patterns of Renal Recovery and Toxicity with Novel Agent-Based Induction Triplets in Newly Diagnosed Multiple Myeloma - an Analysis of Two Prospective Studies By the German DSMM Myeloma Study Group

Author

Bachmann, Friederike, primary, Held, Swantje, additional, Engelhardt, Monika, additional, Langer, Christian, additional, Wolleschak, Denise, additional, Fleissner, Janik, additional, Mügge, Lars-Olof, additional, Duerk, Heinz, additional, Schreder, Martin, additional, Schaefer-Eckart, Kerstin, additional, Blau, Igor-Wolfgang, additional, Gramatzki, Martin, additional, Liebisch, Peter, additional, Reichle, Albrecht, additional, Metzler, Ivana, additional, Bassermann, Florian, additional, Metzner, Bernd, additional, Röllig, Christoph, additional, Hertenstein, Bernd, additional, Dechow, Tobias, additional, Jung, Wolfram, additional, Ostermann, Helmut, additional, Hebart, Holger, additional, Maschmeyer, Georg, additional, Salwender, Hans Jürgen, additional, von Lilienfeld-Toal, Marie, additional, Eckardt, Kai-Uwe, additional, Straka, Christian, additional, Einsele, Hermann, additional, and Knop, Stefan, additional

Published
2019
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236. Chromosomal Abnormalities and Prognosis in NPM1-Mutated Acute Myeloid Leukemia: A Pooled Analysis of Individual Patient Data From Nine International Cohorts

Author

Angenendt, Linus, primary, Röllig, Christoph, additional, Montesinos, Pau, additional, Martínez-Cuadrón, David, additional, Barragan, Eva, additional, García, Raimundo, additional, Botella, Carmen, additional, Martínez, Pilar, additional, Ravandi, Farhad, additional, Kadia, Tapan, additional, Kantarjian, Hagop M., additional, Cortes, Jorge, additional, Juliusson, Gunnar, additional, Lazarevic, Vladimir, additional, Höglund, Martin, additional, Lehmann, Sören, additional, Recher, Christian, additional, Pigneux, Arnaud, additional, Bertoli, Sarah, additional, Dumas, Pierre-Yves, additional, Dombret, Hervé, additional, Preudhomme, Claude, additional, Micol, Jean-Baptiste, additional, Terré, Christine, additional, Ráčil, Zdeněk, additional, Novák, Jan, additional, Žák, Pavel, additional, Wei, Andrew H., additional, Tiong, Ing S., additional, Wall, Meaghan, additional, Estey, Elihu, additional, Shaw, Carole, additional, Exeler, Rita, additional, Wagenführ, Lisa, additional, Stölzel, Friedrich, additional, Thiede, Christian, additional, Stelljes, Matthias, additional, Lenz, Georg, additional, Mikesch, Jan-Henrik, additional, Serve, Hubert, additional, Ehninger, Gerhard, additional, Berdel, Wolfgang E., additional, Kramer, Michael, additional, Krug, Utz, additional, and Schliemann, Christoph, additional

Published
2019
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237. Low-dose melphalan in elderly patients with relapsed or refractory acute myeloid leukemia: A well-tolerated and effective treatment after hypomethylating-agent failure

Author

Stratmann, Jan, primary, van Kann, Elisabeth, additional, Rummelt, Christoph, additional, Koschade, Sebastian, additional, Röllig, Christoph, additional, Lübbert, Michael, additional, Schaich, Markus, additional, Parmentier, Stefani, additional, Sebastian, Martin, additional, Chromik, Joerg, additional, Becker von Rose, Aaron, additional, Ballo, Olivier, additional, Steffen, Björn, additional, Serve, Hubert, additional, Brandts, Christian, additional, and Shaid, Shabnam, additional

Published
2019
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238. Safety and efficacy of oral panobinostat plus chemotherapy in patients aged 65 years or younger with high-risk acute myeloid leukemia

Author

DeAngelo, Daniel J., primary, Walker, Alison R., additional, Schlenk, Richard F., additional, Sierra, Jorge, additional, Medeiros, Bruno C., additional, Ocio, Enrique M., additional, Röllig, Christoph, additional, Strickland, Stephen A., additional, Thol, Felicitas, additional, Valera, Sue-zette, additional, Dasgupta, Kohinoor, additional, Berkowitz, Noah, additional, and Stuart, Robert K., additional

Published
2019
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239. The prevalence of extramedullary acute myeloid leukemia detected by 18FDG-PET/CT: final results from the prospective PETAML trial

Author

Stölzel, Friedrich, primary, Lüer, Tors, additional, Löck, Steffen, additional, Parmentier, Stefani, additional, Kuithan, Friederike, additional, Kramer, Michael, additional, Alakel, Nael S., additional, Sockel, Katja, additional, Taube, Franziska, additional, Middeke, Jan M., additional, Schetelig, Johannes, additional, Röllig, Christoph, additional, Paulus, Tobias, additional, Kotzerke, Jörg, additional, Ehninger, Gerhard, additional, Bornhäuser, Martin, additional, Schaich, Markus, additional, and Zoephel, Klaus, additional

Published
2019
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240. EZH2 mutations and impact on clinical outcome: an analysis in 1,604 patients with newly diagnosed acute myeloid leukemia

Author

Stasik, Sebastian, primary, Middeke, Jan M., additional, Kramer, Michael, additional, Röllig, Christoph, additional, Krämer, Alwin, additional, Scholl, Sebastian, additional, Hochhaus, Andreas, additional, Crysandt, Martina, additional, Brümmendorf, Tim H., additional, Naumann, Ralph, additional, Steffen, Björn, additional, Kunzmann, Volker, additional, Einsele, Hermann, additional, Schaich, Markus, additional, Burchert, Andreas, additional, Neubauer, Andreas, additional, Schäfer-Eckart, Kerstin, additional, Schliemann, Christoph, additional, Krause, Stefan, additional, Herbst, Regina, additional, Hänel, Mathias, additional, Frickhofen, Norbert, additional, Noppeney, Richard, additional, Kaiser, Ulrich, additional, Baldus, Claudia D., additional, Kaufmann, Martin, additional, Rácil, Zdenek, additional, Platzbecker, Uwe, additional, Berdel, Wolfgang E., additional, Mayer, Jiri, additional, Serve, Hubert, additional, Müller-Tidow, Carsten, additional, Ehninger, Gerhard, additional, Bornhäuser, Martin, additional, Schetelig, Johannes, additional, and Thiede, Christian, additional

Published
2019
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242. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Richardson, Paul G, primary, Oriol, Albert, additional, Beksac, Meral, additional, Liberati, Anna Marina, additional, Galli, Monica, additional, Schjesvold, Fredrik, additional, Lindsay, Jindriska, additional, Weisel, Katja, additional, White, Darrell, additional, Facon, Thierry, additional, San Miguel, Jesus, additional, Sunami, Kazutaka, additional, O'Gorman, Peter, additional, Sonneveld, Pieter, additional, Robak, Pawel, additional, Semochkin, Sergey, additional, Schey, Steve, additional, Yu, Xin, additional, Doerr, Thomas, additional, Bensmaine, Amine, additional, Biyukov, Tsvetan, additional, Peluso, Teresa, additional, Zaki, Mohamed, additional, Anderson, Kenneth, additional, Dimopoulos, Meletios, additional, Abildgaard, Niels, additional, Adler, Howard, additional, Altuntas, Fevzi, additional, Akay, Olga Meltem, additional, Amin, Bipinkumar, additional, Anagnostopoulos, Achilleas, additional, Anderson, Larry, additional, Anttila, Pekka, additional, Araujo, Carla, additional, Arce-Lara, Carlos, additional, Aydin, Yildiz, additional, Basu, Supratik, additional, Battini, Ramakrishna, additional, Beeker, Thaddeus, additional, Benboubker, Lotfi, additional, Ben-Yehuda, Dina, additional, Bladé, Joan, additional, Blau, Igor Wolfgang, additional, Boccia, Ralph, additional, Burke, Lillian, additional, Byeff, Peter, additional, Cascavilla, Nicola, additional, Cavo, Michele, additional, Chantry, Andrew, additional, Charles, Yen, additional, Chaudhry, Arvind, additional, Corso, Alessandro, additional, Coyne, Mark, additional, De Arriba, Felipe, additional, Delimpasi, Sosana, additional, Desjardins, Pierre, additional, Dhakal, Binod, additional, Di Bartolomeo, Paolo, additional, Di Raimondo, Francesco, additional, Dürig, Jan, additional, Engelhardt, Monika, additional, Escoffre-Barbe, Martine, additional, Esteves, Graca, additional, Flogegard, Max, additional, Gabrail, Nashat, additional, Gamberi, Barbara, additional, Garrison, Mitchell, additional, Gay, Julie, additional, Gisslinger, Heinz, additional, Goldschmidt, Hartmut, additional, Goncalves, Cristina, additional, Gressot, Laurent, additional, Grosicki, Sebastian, additional, Hanna, Wahid, additional, Hayden, Patrick, additional, Henriques Bernardo, Maria Manuela, additional, Hermann, Robert, additional, Holden, Viran, additional, Honkalehto, Kirsti, additional, Huben, Marianne, additional, Huffman, John, additional, Hunter, Hannah, additional, Hus, Marek, additional, Jagasia, Madan, additional, Jagganath, Sundar, additional, Janakiram, Murali, additional, Jaiyesimi, Ishmael, additional, Jenner, Matthew, additional, João, Cristina, additional, Johnson, Peter, additional, Jurcyszyn, Artur, additional, Kalayoğlu Beşişik, Sevgi, additional, Kambhampati, Suman, additional, Kanate, Abraham, additional, Karadoğan, Ihsan, additional, Khojasteh, Ali, additional, Kirkel, Dean, additional, Komarnicki, Mieczyslaw, additional, Krauth, Maria-Theresa, additional, Kuriakose, Phillip, additional, Larocca, Alessandra, additional, Lauri, Birgitta, additional, Leleu, Xavier, additional, Lucio, Paulo, additional, Luppi, Mario, additional, Mangiacavalli, Silvia, additional, Mariette, Clara, additional, Matsue, Kosei, additional, Mellqvist, Ulf-Henri, additional, Mendeleeva, Larisa, additional, Meshad, Michael, additional, Miller, Carole, additional, Mohrbacher, Ann, additional, Moreau, Philippe, additional, Morelli, Anna Maria, additional, Müldür, Ercan, additional, Naassan, Anthony, additional, Nahi, Hareth, additional, Nair, Rajesh, additional, O'Dwyer, Mike, additional, Öngören Aydin, Seniz, additional, Openshaw, Thomas, additional, O'Rourke, Timothy, additional, Osswald, Michael, additional, Overton, Lindsay, additional, Pati, Asmin, additional, Pavic, Michel, additional, Pegourie, Brigitte, additional, Pehlivan, Mustafa, additional, Pierola, Ana Alfonso, additional, Plesner, Torben, additional, Pluta, Andrzej, additional, Rabin, Neil, additional, Ramasamy, Karthik, additional, Rambaldi, Alessandro, additional, Rodriguez, Paula, additional, Röllig, Christoph, additional, Rosenblatt, Jacalyn, additional, Rosenbluth, Jonathan, additional, Salomo, Morten, additional, Samoylova, Olga, additional, Sastre Moral, Jose, additional, Sati, Hamdi, additional, Selleri, Carmine, additional, Shafeek, Salim, additional, Shinagawa, Atsushi, additional, Sleckman, Bethany, additional, Smith, Clay, additional, Sonmez, Mehmet, additional, Stone, Chester, additional, Streetly, Matthew, additional, Suzuki, Kenshi, additional, Taetle, Raymond, additional, Tafuri, Agostino, additional, Takezako, Naoki, additional, Teke, Hava Üsküdar, additional, Vapaatalo, Mirja, additional, Vassilopoulos, George, additional, Verma, Amit, additional, Vidito, Sarah, additional, Viterbo, Luisa, additional, Vural, Filiz, additional, Wang, Xiang Sean, additional, Yağci, Munci, additional, and Yee, Andrew, additional

Published
2019
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243. MIRROS: An ongoing randomized phase 3 trial of idasanutlin + ARA-C in patients with relapsed or refractory acute myeloid leukemia.

Author

Montesinos, Pau, primary, Esteve, Jordi, additional, Konopleva, Marina, additional, Martinelli, Giovanni, additional, Ottmann, Oliver, additional, Rodriguez-Veiga, Rebeca, additional, Röllig, Christoph, additional, Wei, Andrew, additional, Vey, Norbert, additional, Chiu, Idy, additional, Monnet, Annabelle, additional, Ott, Marion Gabriele, additional, and Fenaux, Pierre, additional

Published
2019
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244. Differential impact of IDH1/2 mutational subclasses on outcome in adult AML: results from a large multicenter study

Author

Middeke, Jan M., Metzeler, Klaus H., Röllig, Christoph, Krämer, Michael, Eckardt, Jan-Niklas, Stasik, Sebastian, Greif, Philipp A., Spiekermann, Karsten, Rothenberg-Thurley, Maja, Krug, Utz, Braess, Jan, Krämer, Alwin, Hochhaus, Andreas, Brümmendorf, Tim H., Naumann, Ralph, Steffen, Björn, Einsele, Hermann, Schaich, Markus, Burchert, Andreas, Neubauer, Andreas, Görlich, Dennis, Sauerland, Cristina, Schäfer-Eckart, Kerstin, Schliemann, Christoph, Krause, Stefan W., Hänel, Mathias, Frickhofen, Norbert, Noppeney, Richard, Kaiser, Ulrich, Kaufmann, Martin, Kunadt, Desiree, Wörmann, Bernhard, Sockel, Katja, von Bonin, Malte, Herold, Tobias, Müller-Tidow, Carsten, Platzbecker, Uwe, Berdel, Wolfgang E., Serve, Hubert, Baldus, Claudia D., Ehninger, Gerhard, Schetelig, Johannes, Hiddemann, Wolfgang, Bornhäuser, Martin, Stölzel, Friedrich, and Thiede, Christian

Abstract

Mutations of the isocitrate dehydrogenase-1 (IDH1) and IDH2 genes are among the most frequent alterations in acute myeloid leukemia (AML) and can be found in ∼20% of patients at diagnosis. Among 4930 patients (median age, 56 years; interquartile range, 45-66) with newly diagnosed, intensively treated AML, we identified IDH1 mutations in 423 (8.6%) and IDH2 mutations in 575 (11.7%). Overall, there were no differences in response rates or survival for patients with mutations in IDH1 or IDH2 compared with patients without mutated IDH1/2. However, distinct clinical and comutational phenotypes of the most common subtypes of IDH1/2 mutations could be associated with differences in outcome. IDH1-R132C was associated with increased age, lower white blood cell (WBC) count, less frequent comutation of NPM1 and FLT3 internal tandem mutation (ITD) as well as with lower rate of complete remission and a trend toward reduced overall survival (OS) compared with other IDH1 mutation variants and wild-type (WT) IDH1/2. In our analysis, IDH2-R172K was associated with significantly lower WBC count, more karyotype abnormalities, and less frequent comutations of NPM1 and/or FLT3-ITD. Among patients within the European LeukemiaNet 2017 intermediate- and adverse-risk groups, relapse-free survival and OS were significantly better for those with IDH2-R172K compared with WT IDH, providing evidence that AML with IDH2-R172K could be a distinct entity with a specific comutation pattern and favorable outcome. In summary, the presented data from a large cohort of patients with IDH1/2 mutated AML indicate novel and clinically relevant findings for the most common IDH mutation subtypes.

Published
2022
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245. Decitabine treatment in 311 patients with acute myeloid leukemia: outcome and impact of TP53 mutations – a registry based analysis.

Author

Middeke, Jan M., Teipel, Raphael, Röllig, Christoph, Stasik, Sebastian, Zebisch, Armin, Sill, Heinz, Kramer, Michael, Scholl, Sebastian, Hochhaus, Andreas, Jost, Edgar, Brümmendorf, Tim H., Naumann, Ralph, Steffen, Björn, Serve, Hubert, Altmann, Heidi, Kunzmann, Volker, Einsele, Hermann, Parmentier, Stefani, Schaich, Markus, and Burchert, Andreas

Subjects
ACUTE myeloid leukemia, TRAUMA registries, OVERALL survival, DECITABINE, SURVIVAL rate, SURVIVAL analysis (Biometry)
Abstract

We performed a registry-based analysis of 311 AML patients treated with decitabine in a standard of care setting to assess response and survival data with a distinct focus on the impact of the TP53 mutation status. Median age was 73 years. 172 patients received decitabine first-line and 139 in r/r disease. The ORR (whole cohort) was 30% with a median overall survival of 4.7 months. First-line patients achieved better responses than r/r-patients (ORR: 38% vs. 21%) resulting in a median OS of 5.8 months vs. 3.9 months. NGS based mutation analysis was performed in 180 patients. 20 patients (11%) harbored a TP53 mutation. Response rates and survival did not differ significantly between TP53 mutated patients and wild-type patients. This analysis of a large cohort of AML patients provides response rates and OS data after decitabine treatment. Interestingly, outcome was not negatively influenced by a TP53 mutation. [ABSTRACT FROM AUTHOR]

Published
2021
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246. Chromosomal Abnormalities and Prognosis in NPM1-Mutated Acute Myeloid Leukemia : A Pooled Analysis of Individual Patient Data From Nine International Cohorts

Author

Angenendt, Linus, Röllig, Christoph, Montesinos, Pau, Martinez-Cuadron, David, Barragan, Eva, Garcia, Raimundo, Botella, Carmen, Martinez, Pilar, Ravandi, Farhad, Kadia, Tapan, Kantarjian, Hagop M., Cortes, Jorge, Juliusson, Gunnar, Lazarevic, Vladimir, Höglund, Martin, Lehmann, Sören, Recher, Christian, Pigneux, Arnaud, Bertoli, Sarah, Dumas, Pierre-Yves, Dombret, Herve, Preudhomme, Claude, Micol, Jean-Baptiste, Terre, Christine, Racil, Zdenek, Novak, Jan, Zak, Pavel, Wei, Andrew H., Tiong, Ing S., Wall, Meaghan, Estey, Elihu, Shaw, Carole, Exeler, Rita, Wagenführ, Lisa, Stölzel, Friedrich, Thiede, Christian, Stelljes, Matthias, Lenz, Georg, Mikesch, Jan-Henrik, Serve, Hubert, Ehninger, Gerhard, Berdel, Wolfgang E., Kramer, Michael, Krug, Utz, Schliemann, Christoph, Angenendt, Linus, Röllig, Christoph, Montesinos, Pau, Martinez-Cuadron, David, Barragan, Eva, Garcia, Raimundo, Botella, Carmen, Martinez, Pilar, Ravandi, Farhad, Kadia, Tapan, Kantarjian, Hagop M., Cortes, Jorge, Juliusson, Gunnar, Lazarevic, Vladimir, Höglund, Martin, Lehmann, Sören, Recher, Christian, Pigneux, Arnaud, Bertoli, Sarah, Dumas, Pierre-Yves, Dombret, Herve, Preudhomme, Claude, Micol, Jean-Baptiste, Terre, Christine, Racil, Zdenek, Novak, Jan, Zak, Pavel, Wei, Andrew H., Tiong, Ing S., Wall, Meaghan, Estey, Elihu, Shaw, Carole, Exeler, Rita, Wagenführ, Lisa, Stölzel, Friedrich, Thiede, Christian, Stelljes, Matthias, Lenz, Georg, Mikesch, Jan-Henrik, Serve, Hubert, Ehninger, Gerhard, Berdel, Wolfgang E., Kramer, Michael, Krug, Utz, and Schliemann, Christoph

Abstract

PURPOSE: Nucleophosmin 1 (NPM1) mutations are associated with a favorable prognosis in acute myeloid leukemia (AML) when an internal tandem duplication (ITD) in the fms-related tyrosine kinase 3 gene (FLT3) is absent (FLT3-ITDneg) or present with a low allelic ratio (FLT3-ITDlow). The 2017 European LeukemiaNet guidelines assume this is true regardless of accompanying cytogenetic abnormalities. We investigated the validity of this assumption. METHODS: We analyzed associations between karyotype and outcome in intensively treated patients with NPM1(mut)/FLT3-ITDneg/low AML who were prospectively enrolled in registry databases from nine international study groups or treatment centers. RESULTS: Among 2,426 patients with NPM1(mut)/FLT3-ITDneg/low AML, 2,000 (82.4%) had a normal and 426 (17.6%) had an abnormal karyotype, including 329 patients (13.6%) with intermediate and 83 patients (3.4%) with adverse-risk chromosomal abnormalities. In patients with NPM1(mut)/FLT3-ITDneg/low AML, adverse cytogenetics were associated with lower complete remission rates (87.7%, 86.0%, and 66.3% for normal, aberrant intermediate, and adverse karyotype, respectively; P < .001), inferior 5-year overall (52.4%, 44.8%, 19.5%, respectively; P < .001) and event-free survival (40.6%, 36.0%, 18.1%, respectively; P < .001), and a higher 5-year cumulative incidence of relapse (43.6%, 44.2%, 51.9%, respectively; P = .0012). These associations remained in multivariable mixed-effects regression analyses adjusted for known clinicopathologic risk factors (P < .001 for all end points). In patients with adverse-risk chromosomal aberrations, we found no significant influence of the NPM1 mutational status on outcome. CONCLUSION: Karyotype abnormalities are significantly associated with outcome in NPM1(mut)/FLT3-ITDneg/low AML. When adverse-risk cytogenetics are present, patients with NPM1(mut) share the same unfavorable prognosis as patients with NPM1 wild type and should be classified and treate

Published
2019
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247. Safety and efficacy of oral panobinostat plus chemotherapy in patients aged 65 years or younger with high-risk acute myeloid leukemia

Author

Novartis, DeAngelo, Daniel J., Walker, Alison R., Schlenk, Richard F., Sierra, Jorge, Medeiros, Bruno C., Ocio, Enrique M., Röllig, Christoph, Stricklandh, Stephen A., Thol, Felicitas, Valera, Sue-zette, Dasgupta, Kohinoor, Berkowitz, Noah, Stuart, Robert K., Novartis, DeAngelo, Daniel J., Walker, Alison R., Schlenk, Richard F., Sierra, Jorge, Medeiros, Bruno C., Ocio, Enrique M., Röllig, Christoph, Stricklandh, Stephen A., Thol, Felicitas, Valera, Sue-zette, Dasgupta, Kohinoor, Berkowitz, Noah, and Stuart, Robert K.

Abstract

The role of histone deacetylase inhibitors in the treatment of acute myeloid leukemia (AML) is not well characterized. The current study evaluated the safety and efficacy of panobinostat in combination with idarubicin and cytarabine in newly diagnosed patients aged ≤65 years with primary or secondary high-risk AML based on cytogenetic classification. Treatment included fixed dose idarubicin (12 mg/m2/d, IV; day 1–3) and cytarabine (100 mg/m2/d, continuous IV infusion; day 1–7) and escalating oral doses of panobinostat at 15 mg, 20 mg, and 25 mg, thrice weekly starting at week 2 of a 28-day cycle. Forty-six patients were enrolled (primary AML [n = 36], secondary AML [n = 10]). The median age was 55 years. The most common all-grade AEs were diarrhea (54.3%), nausea (39.1%), vomiting, and decreased appetite (each, 21.7%), stomatitis (19.6%), and fatigue (17.4%). The overall response rate was 60.9%, 43.5% achieved a complete remission (CR), and 17.4% achieved CR with incomplete count recovery. The event-free survival at 1-year was 78.3%. Panobinostat in combination with idarubicin and cytarabine demonstrated tolerable safety and efficacy in younger patients with high-risk AML. The recommended phase 2 dose of panobinostat in this combination was 20 mg. ClinicalTrials.gov registry no: NCT01242774, and European Trial Registry EudraCT no: 2009-016809-42.

Published
2019

248. CEBPA mutations in 4708 patients with acute myeloid leukemia: differential impact of bZIP and TAD mutations on outcome

Author

Taube, Franziska, Georgi, Julia Annabell, Kramer, Michael, Stasik, Sebastian, Middeke, Jan Moritz, Röllig, Christoph, Krug, Utz, Krämer, Alwin, Scholl, Sebastian, Hochhaus, Andreas, Brümmendorf, Tim H., Naumann, Ralph, Petzold, Andreas, Mulet-Lazaro, Roger, Valk, Peter J. M., Steffen, Björn, Einsele, Hermann, Schaich, Markus, Burchert, Andreas, Neubauer, Andreas, Schäfer-Eckart, Kerstin, Schliemann, Christoph, Krause, Stefan W., Hänel, Mathias, Noppeney, Richard, Kaiser, Ulrich, Baldus, Claudia D., Kaufmann, Martin, Herold, Sylvia, Stölzel, Friedrich, Sockel, Katja, von Bonin, Malte, Müller-Tidow, Carsten, Platzbecker, Uwe, Berdel, Wolfgang E., Serve, Hubert, Ehninger, Gerhard, Bornhäuser, Martin, Schetelig, Johannes, and Thiede, Christian

Abstract

Biallelic mutations of the CEBPA gene (CEBPAbi) define a distinct entity associated with favorable prognosis; however, the role of monoallelic mutations (CEBPAsm) is poorly understood. We retrospectively analyzed 4708 adults with acute myeloid leukemia (AML) who had been recruited into the Study Alliance Leukemia trials, to investigate the prognostic impact of CEBPAsm. CEBPA mutations were identified in 240 patients (5.1%): 131 CEBPAbi and 109 CEBPAsm (60 affecting the N-terminal transactivation domains [CEBPAsmTAD] and 49 the C-terminal DNA-binding or basic leucine zipper region [CEBPAsmbZIP]). Interestingly, patients carrying CEBPAbi or CEBPAsmbZIP shared several clinical factors: they were significantly younger (median, 46 and 50 years, respectively) and had higher white blood cell (WBC) counts at diagnosis (median, 23.7 × 109/L and 35.7 × 109/L) than patients with CEBPAsmTAD (median age, 63 years, median WBC 13.1 × 109/L; P < .001). Co-mutations were similar in both groups: GATA2 mutations (35.1% CEBPAbi; 36.7% CEBPAsmbZIP vs 6.7% CEBPAsmTAD; P < .001) or NPM1 mutations (3.1% CEBPAbi; 8.2% CEBPAsmbZIP vs 38.3% CEBPAsmTAD; P < .001). CEBPAbi and CEBPAsmbZIP, but not CEBPAsmTAD were associated with significantly improved overall (OS; median 103 and 63 vs 13 months) and event-free survival (EFS; median, 20.7 and 17.1 months vs 5.7 months), in univariate and multivariable analyses. Additional analyses revealed that the clinical and molecular features as well as the favorable survival were confined to patients with in-frame mutations in bZIP (CEBPAbZIP-inf). When patients were classified according to CEBPAbZIP-inf and CEBPAother (including CEBPAsmTAD and non-CEBPAbZIP-inf), only patients bearing CEBPAbZIP-inf showed superior complete remission rates and the longest median OS and EFS, arguing for a previously undefined prognostic role of this type of mutation.

Published
2022
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249. CEBPAmutations in 4708 patients with acute myeloid leukemia: differential impact of bZIP and TAD mutations on outcome

Author

Taube, Franziska, Georgi, Julia Annabell, Kramer, Michael, Stasik, Sebastian, Middeke, Jan Moritz, Röllig, Christoph, Krug, Utz, Krämer, Alwin, Scholl, Sebastian, Hochhaus, Andreas, Brümmendorf, Tim H., Naumann, Ralph, Petzold, Andreas, Mulet-Lazaro, Roger, Valk, Peter J.M., Steffen, Björn, Einsele, Hermann, Schaich, Markus, Burchert, Andreas, Neubauer, Andreas, Schäfer-Eckart, Kerstin, Schliemann, Christoph, Krause, Stefan W., Hänel, Mathias, Noppeney, Richard, Kaiser, Ulrich, Baldus, Claudia D., Kaufmann, Martin, Herold, Sylvia, Stölzel, Friedrich, Sockel, Katja, von Bonin, Malte, Müller-Tidow, Carsten, Platzbecker, Uwe, Berdel, Wolfgang E., Serve, Hubert, Ehninger, Gerhard, Bornhäuser, Martin, Schetelig, Johannes, and Thiede, Christian

Abstract

Biallelic mutations of the CEBPAgene (CEBPAbi) define a distinct entity associated with favorable prognosis; however, the role of monoallelic mutations (CEBPAsm) is poorly understood. We retrospectively analyzed 4708 adults with acute myeloid leukemia (AML) who had been recruited into the Study Alliance Leukemia trials, to investigate the prognostic impact of CEBPAsm. CEBPAmutations were identified in 240 patients (5.1%): 131 CEBPAbiand 109 CEBPAsm(60 affecting the N-terminal transactivation domains [CEBPAsmTAD] and 49 the C-terminal DNA-binding or basic leucine zipper region [CEBPAsmbZIP]). Interestingly, patients carrying CEBPAbior CEBPAsmbZIPshared several clinical factors: they were significantly younger (median, 46 and 50 years, respectively) and had higher white blood cell (WBC) counts at diagnosis (median, 23.7 × 109/L and 35.7 × 109/L) than patients with CEBPAsmTAD(median age, 63 years, median WBC 13.1 × 109/L; P< .001). Co-mutations were similar in both groups: GATA2mutations (35.1% CEBPAbi; 36.7% CEBPAsmbZIPvs 6.7% CEBPAsmTAD; P< .001) or NPM1mutations (3.1% CEBPAbi; 8.2% CEBPAsmbZIPvs 38.3% CEBPAsmTAD; P< .001). CEBPAbiand CEBPAsmbZIP, but not CEBPAsmTADwere associated with significantly improved overall (OS; median 103 and 63 vs 13 months) and event-free survival (EFS; median, 20.7 and 17.1 months vs 5.7 months), in univariate and multivariable analyses. Additional analyses revealed that the clinical and molecular features as well as the favorable survival were confined to patients with in-frame mutations in bZIP (CEBPAbZIP-inf). When patients were classified according to CEBPAbZIP-infand CEBPAother(including CEBPAsmTADand non-CEBPAbZIP-inf), only patients bearing CEBPAbZIP-infshowed superior complete remission rates and the longest median OS and EFS, arguing for a previously undefined prognostic role of this type of mutation.

Published
2022
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250. Leitlinie - ICD-10 C92.-, ICD-10 C93.- : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie hämatologischer und onkologischer Erkrankungen

Author

Schweizerische Gesellschaft Für Hämatologie, Schlenk, Richard Friedrich, Schweizerische Gesellschaft Für Medizinische Onkologie, Gesellschaft Für Pädiatrische Onkologie Und Hämatologie, Niederwieser, Dietger, Reinhardt, Dirk, Österreichische Gesellschaft Für Hämatologie & Medizinische Onkologie, Greil, Richard, Braess, Jan, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie, Beelen, Dietrich W., Passweg, Jakob R., and Röllig, Christoph

Subjects
Medizin und Gesundheit
Published
2018
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