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2. Enasidenib vs conventional care in older patients with late-stage mutant-IDH2 relapsed/refractory AML: a randomized phase 3 trial

Author

de Botton, Stéphane, Montesinos, Pau, Schuh, Andre C., Papayannidis, Cristina, Vyas, Paresh, Wei, Andrew H., Ommen, Hans, Semochkin, Sergey, Kim, Hee-Je, Larson, Richard A., Koprivnikar, Jaime, Frankfurt, Olga, Thol, Felicitas, Chromik, Jörg, Byrne, Jenny, Pigneux, Arnaud, Thomas, Xavier, Salamero, Olga, Vidriales, Maria Belen, Doronin, Vadim, Döhner, Hartmut, Fathi, Amir T., Laille, Eric, Yu, Xin, Hasan, Maroof, Martin-Regueira, Patricia, and DiNardo, Courtney D.

Published
2023
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4. Real‐world effectiveness of first‐line azacitidine or decitabine with or without venetoclax in acute myeloid leukemia patients unfit for intensive therapy.

Author

Acker, Fabian, Chromik, Jörg, Tiedjen, Emily, Wolf, Sebastian, Vischedyk, Jonas B., Makowka, Philipp, Enßle, Julius C., Kouidri, Khouloud, Sebastian, Martin, Steffen, Björn, Oellerich, Thomas, Serve, Hubert, Neubauer, Andreas, Schäfer, Jonas A., and Bittenbring, Jörg T.

Subjects
*ACUTE myeloid leukemia, *VENETOCLAX, *AZACITIDINE, *DECITABINE, *OVERALL survival
Abstract

Background Methods Results Discussion First‐line treatment in patients with acute myeloid leukemia (AML) unfit for intensive therapy is the combination of a hypomethylating agent (HMA) with venetoclax (VEN). However, retrospective data confirming the benefits of this regimen outside of clinical trials have shown conflicting results.We performed a multicenter retrospective analysis of outcomes with first‐line HMA–VEN versus HMA in AML patients unfit for intensive chemotherapy.A total of 213 patients were included from three German hospitals (125 HMA–VEN, 88 HMA). Median overall survival in the HMA–VEN cohort was 7.9 months (95% confidence interval [CI], 5.1–14.7) versus 4.9 months (3.1–7.1) with HMA. After 1 year, 42% (95% CI, 33–54) and 19% (12–30) of patients were alive, respectively (hazard ratio [HR] for death, 0.64; 95% CI, 0.46–0.88). After adjusting for clinical and molecular baseline characteristics, treatment with HMA–VEN remained significantly associated with both prolonged survival (HR, 0.48; 95% CI, 0.29–0.77) and time to next treatment (HR, 0.63; 95% CI, 0.47–0.85). Patients who achieved recovery of peripheral blood counts had a favorable prognosis (HR for death, 0.52; 95% CI, 0.33–0.84).These data align with findings from the pivotal VIALE‐A trial and support the use of HMA–VEN in patients unfit for intensive therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Autoreninnen und Autoren

Author

Ahrens, Marit, primary, Al-Batran, Salah-Eddin, additional, Armbrust, Robert, additional, Banek, Séverine, additional, Becker, Sven, additional, Bergmann, Lothar, additional, Bojunga, Jörg, additional, Brümmendorf, Tim Henrik, additional, Brunnberg, Uta, additional, Bug, Gesine, additional, Burger, Michael, additional, Chromik, Jörg, additional, Chun, Felix K.-H., additional, Czauderna, Carolin, additional, Dumoulin, Franz Ludwig, additional, Dreyling, Martin, additional, El-Balat, Ahmed, additional, Ellinger, Jörg, additional, Elsner, Susanne, additional, Enßle, Julius C., additional, Fottner, Christian, additional, Galle, Peter R., additional, Gökbuget, Nicola, additional, Götze, Thorsten Oliver, additional, Halbsguth, Teresa, additional, Höh, Benedikt, additional, Hohenberger, Peter, additional, Hübner, Joachim, additional, Hübner, Jutta, additional, Isfort, Susanne, additional, Kasper, Bernd, additional, Katalinic, Alexander, additional, Kestler, Angelika, additional, Khodamoradi, Yascha, additional, Kleemann, Johannes, additional, Kluth, Luis A., additional, Köhler, Viktoria F., additional, Kollmar, Otto, additional, Koschmieder, Steffen, additional, Lang, Fabian, additional, Makowka, Philipp, additional, Mallmann, Peter, additional, Mallmann-Gottschalk, Nina, additional, Mandel, Philipp, additional, Maurer, Gabriele, additional, Mayer, Arnulf, additional, Meissner, Markus, additional, Menge, Franka, additional, Middeke, Jan Moritz, additional, Miesbach, Wolfgang, additional, Möhler, Markus, additional, Möbus, Volker, additional, Müller, Stefan C., additional, Musholt, Thomas J., additional, Nauck, Friedemann, additional, Oellerich, Thomas, additional, Özistanbullu, Deniz, additional, Porschen, Rainer, additional, Pox, Christian, additional, Richter, Konrad Klaus, additional, Sauerbruch, Tilman, additional, Scheich, Sebastian, additional, Schetelig, . Johannes, additional, Schmidberger, Heinz, additional, Schnürch, Hans-Georg, additional, Sebastian, Martin, additional, Sehouli, Jalid, additional, Seifart, Ulf, additional, Serve, Hubert, additional, Seufferlein, Thomas, additional, Shaid, Shabnam, additional, Soysal, Savas D., additional, Steffen, Björn, additional, Steinbach, Joachim P., additional, Stratmann, Jan A., additional, Tsoukakis, Ioannis, additional, Ullrich, Evelyn, additional, Vehreschild, Janne, additional, Metzler, Ivana von, additional, Wolff, Michael von, additional, Voß, Martin, additional, Wagner, Sebastian, additional, Weber, Matthias M., additional, Wege, Henning, additional, Weis, Joachim, additional, Welte, Maria-Noemi, additional, Wenzel, Mike, additional, Wolf, Timo, additional, and Zurmeyer, David, additional

Published
2022
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7. 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, van Kann, Elisabeth, Rummelt, Christoph, Koschade, Sebastian, Röllig, Christoph, Lübbert, Michael, Schaich, Markus, Parmentier, Stefani, Sebastian, Martin, Chromik, Joerg, Becker von Rose, Aaron, Ballo, Olivier, Steffen, Björn, Serve, Hubert, Brandts, Christian, and Shaid, Shabnam

Published
2019
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9. Identification of Adult Patients With Classical Dyskeratosis Congenita or Cryptic Telomere Biology Disorder by Telomere Length Screening Using Age-modified Criteria

Author

Tometten, Mareike, primary, Kirschner, Martin, additional, Meyer, Robert, additional, Begemann, Matthias, additional, Halfmeyer, Insa, additional, Vieri, Margherita, additional, Kricheldorf, Kim, additional, Maurer, Angela, additional, Platzbecker, Uwe, additional, Radsak, Markus, additional, Schafhausen, Philippe, additional, Corbacioglu, Selim, additional, Höchsmann, Britta, additional, Matthias Wilk, C., additional, Hinze, Claas, additional, Chromik, Jörg, additional, Heuser, Michael, additional, Kreuter, Michael, additional, Koschmieder, Steffen, additional, Panse, Jens, additional, Isfort, Susanne, additional, Kurth, Ingo, additional, Brümmendorf, Tim H., additional, and Beier, Fabian, additional

Published
2023
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10. Supplementary Data from Results from a First-in-Human Phase I Study of Siremadlin (HDM201) in Patients with Advanced Wild-Type TP53 Solid Tumors and Acute Leukemia

Author

Stein, Eytan M., primary, DeAngelo, Daniel J., primary, Chromik, Jörg, primary, Chatterjee, Manik, primary, Bauer, Sebastian, primary, Lin, Chia-Chi, primary, Suarez, Cristina, primary, de Vos, Filip, primary, Steeghs, Neeltje, primary, Cassier, Philippe A., primary, Tai, David, primary, Kiladjian, Jean-Jacques, primary, Yamamoto, Noboru, primary, Mous, Rogier, primary, Esteve, Jordi, primary, Minami, Hironobu, primary, Ferretti, Stephane, primary, Guerreiro, Nelson, primary, Meille, Christophe, primary, Radhakrishnan, Rajkumar, primary, Pereira, Bernard, primary, Mariconti, Luisa, primary, Halilovic, Ensar, primary, Fabre, Claire, primary, and Carpio, Cecilia, primary

Published
2023
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12. Autoren

Author

Aguinarte, Lukas J., Ahrens, Marit, Armbrust, Robert, Becker, Sven, Bergmann, Lothar, Bojunga, Jörg, Bug, Gesine, Büntzel, Jens, Burger, Michael, Chromik, Jörg, Chun, Felix K.-H., Dumoulin, Franz Ludwig, Dreyling, Martin, Ebert, Matthias, El-Balat, Ahmed, Ellinger, Jörg, Elsner, Susanne, Enßle, Julius C., Fottner, Christian, Gökbuget, Nicola, Götze, Thorsten Oliver, Halbsguth, Teresa, Hartmann, Sylvia, Höh, Benedikt, Hohenberger, Peter, Hübner, Joachim, Hübner, Jutta, Isfort, Susanne, Kasper, Bernd, Kestler, Angelika, Kleemann, Johannes, Kluth, Luis A., Köhler, Viktoria F., Kollmar, Otto, Lang, Fabian, Makowka, Philipp, Mallmann-Gottschalk, Nina, Mandel, Philipp, Maurer, Gabriele D., Mayer, Arnulf, Meissner, Markus, Menge, Franka, Middeke, Jan Moritz, Miesbach, Wolfgang, Möhler, Markus, Möbus, Volker, Müller, Stefan C., Nauck, Friedemann, Oellerich, Thomas, Özistanbullu, Deniz, Pox, Christian, Richter, Konrad Klaus, Scheich, Sebastian, Schetelig, Johannes, Schnürch, Hans-Georg, Sehouli, Jalid, Seifart, Ulf, Serve, Hubert, Seufferlein, Thomas, Shaid, Shabnam, Soysal, Savas D., Staubitz, Julia I., Steffen, Björn, Steinbach, Joachim P., Stratmann, Jan A., Tsoukakis, Ioannis, Ullrich, Evelyn, Vehreschild, Janne, Metzler, Ivana von, Wolff, Michael von, Voß, Martin, Wagner, Sebastian, Weber, Matthias M., Weber, Sarah, Wege, Henning, Weis, Joachim, Welte, Maria-Noemi, Wenzel, Mike, Wölber, Linn, Wolf, Timo, Zimpel, Carolin, Zurmeyer, David, and Zurmeyer, Sarah

Published
2024
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13. Results from a First-in-Human Phase I Study of Siremadlin (HDM201) in Patients with Advanced Wild-Type TP53 Solid Tumors and Acute Leukemia

Author

Stein, Eytan M., primary, DeAngelo, Daniel J., additional, Chromik, Jörg, additional, Chatterjee, Manik, additional, Bauer, Sebastian, additional, Lin, Chia-Chi, additional, Suarez, Cristina, additional, de Vos, Filip, additional, Steeghs, Neeltje, additional, Cassier, Philippe A., additional, Tai, David, additional, Kiladjian, Jean-Jacques, additional, Yamamoto, Noboru, additional, Mous, Rogier, additional, Esteve, Jordi, additional, Minami, Hironobu, additional, Ferretti, Stephane, additional, Guerreiro, Nelson, additional, Meille, Christophe, additional, Radhakrishnan, Rajkumar, additional, Pereira, Bernard, additional, Mariconti, Luisa, additional, Halilovic, Ensar, additional, Fabre, Claire, additional, and Carpio, Cecilia, additional

Published
2021
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14. Clinical Presentation of Patients with Adult Late-Onset Telomere Biology Disorders - Results from the Aachen Telomeropathy Registry

Author

Beier, Fabian, primary, Tometten, Mareike, additional, Kirschner, Martin, additional, Halfmeyer, Insa, additional, Vieri, Margherita, additional, Kricheldorf, Kim, additional, Maurer, Angela, additional, Roeth, Alexander, additional, Platzbecker, Uwe, additional, Radsak, Markus P., additional, Schafhausen, Philippe, additional, Corbacioglu, Selim, additional, Hoechsmann, Britta, additional, Wilk, C. Matthias, additional, Hinze, Claas, additional, Chromik, Jörg, additional, Egle, Alexander, additional, Heuser, Michael, additional, Kreuter, Michael, additional, Kurth, Ingo, additional, Koschmieder, Steffen, additional, Panse, Jens, additional, Meyer, Robert, additional, Isfort, Susanne, additional, and Brummendorf, Tim H, additional

Published
2021
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15. Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Patients with Lower-Risk Myelodysplastic Syndromes

Author

Haque, Tamanna, primary, Cadenas, Felix López, additional, Xicoy, Blanca, additional, Alfonso, Ana, additional, Platzbecker, Uwe, additional, Avivi, Irit, additional, Brunner, Andrew M., additional, Chromik, Jörg, additional, Morillo, Daniel, additional, Patel, Manish R., additional, Falantes, José F., additional, Leitch, Heather A., additional, Germing, Ulrich, additional, Preis, Meir, additional, Lavie, David, additional, Lenox, Laurie, additional, Lauring, Josh, additional, Kalota, Anna, additional, Brown, Regina, additional, Mehta, Jaydeep, additional, Pastore, Friederike, additional, Mistry, Pankaj, additional, and Valcarcel, David, additional

Published
2021
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16. Siremadlin (HDM201) Is Well Tolerated and Demonstrates Clinical Activity in Patients with Acute Myeloid Leukemia Who Have Relapsed after Allogeneic Stem Cell Transplantation: A Subset Analysis of Safety and Preliminary Efficacy

Author

Stein, Eytan M., primary, Chromik, Jörg, additional, Carpio, Cecilia, additional, Mous, Rogier, additional, Kiladjian, Jean-Jacques, additional, Alatrash, Gheath, additional, Curti, Antonio, additional, Craddock, Charles, additional, Schmid, Christoph, additional, Zeiser, Robert, additional, Eldjerou, Lamis K., additional, Weber, Hans-Jochen Jochen, additional, Fabre, Claire, additional, Scott, Jeffrey, additional, and DeAngelo, Daniel J., additional

Published
2021
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17. Bemcentinib (Oral AXL Inhibitor) in Combination with Low-Dose Cytarabine Is Well Tolerated and Efficacious in Older Relapsed AML Patients.Updates from the Ongoing Phase II Trial (NCT02488408) and Preliminary Translational Results Indicating Bemcentinib Elicits Anti-AML Immune Responses

Author

Loges, Sonja, primary, Sutamtewagul, Grerk, additional, Heuser, Michael, additional, Chromik, Jörg, additional, Kapp-Schwoerer, Silke, additional, Crugnola, Monica, additional, Di Renzo, Nicola, additional, Lemoli, Roberto M., additional, Mattei, Daniele Giovanni, additional, Ben Batalla, Isabel, additional, Hellesøy, Monica, additional, Waizenegger, Jonas, additional, Janning, Melanie, additional, Imbusch, Charles D., additional, Beumer, Niklas, additional, Rayford, Austin, additional, Nautiyal, Jaya, additional, Berkman-Gottlieb, Tzivia, additional, Micklem, David, additional, Gabra, Hani, additional, Gorcea-Carson, Claudia, additional, Lorens, James B., additional, Fiedler, Walter, additional, Alvarado, Yesid, additional, Gjertsen, Bjorn T., additional, and Rieckmann, Lisa-Marie, additional

Published
2021
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18. Molecular Response Patterns in Relapsed/Refractory AML Patients Treated with Selinexor and Chemotherapy

Author

Klement, Piroska, primary, Fiedler, Walter, additional, Gabdoulline, Razif, additional, Dallmann, Louisa-Kristin, additional, Wienecke, Clara, additional, Schiller, Johannes, additional, Kandziora, Christian, additional, Teich, Katrin, additional, Heida, Bennet, additional, Brandes, Maximilian, additional, Funke, Carolin, additional, Wichmann, Martin, additional, Othman, Basem, additional, Chromik, Jörg, additional, Büttner, Konstantin, additional, Amberg, Stefanie, additional, Kebenko, Maxim, additional, Schlipfenbacher, Vera, additional, Wilke, Anne C, additional, Modemann, Franziska, additional, Janning, Melanie, additional, Serve, Hubert, additional, Bokemeyer, Carsten, additional, Deppermann, Ute, additional, Kranich, Anne L., additional, Ganser, Arnold, additional, Thol, Felicitas, additional, and Heuser, Michael, additional

Published
2021
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19. Enasidenib vs conventional care in older patients with late-stage mutant-IDH2relapsed/refractory AML: a randomized phase 3 trial

Author

de Botton, Stéphane, Montesinos, Pau, Schuh, Andre C., Papayannidis, Cristina, Vyas, Paresh, Wei, Andrew H., Ommen, Hans, Semochkin, Sergey, Kim, Hee-Je, Larson, Richard A., Koprivnikar, Jaime, Frankfurt, Olga, Thol, Felicitas, Chromik, Jörg, Byrne, Jenny, Pigneux, Arnaud, Thomas, Xavier, Salamero, Olga, Vidriales, Maria Belen, Doronin, Vadim, Döhner, Hartmut, Fathi, Amir T., Laille, Eric, Yu, Xin, Hasan, Maroof, Martin-Regueira, Patricia, and DiNardo, Courtney D.

Abstract

•EFS was meaningfully improved with enasidenib vs CCR; OS was confounded by early dropout and use of subsequent AML therapies.•Enasidenib provided meaningful morphologic and hematologic responses vs CCR in this heavily pretreated older R/R mutant-IDH2AML population.

Published
2023
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20. The Combination of AXL Inhibitor Bemcentinib and Low Dose Cytarabine Is Well Tolerated and Efficacious in Elderly Relapsed AML Patients: Update from the Ongoing BGBC003 Phase II Trial (NCT02488408)

Author

Loges, Sonja, primary, Heuser, Michael, additional, Chromik, Jörg, additional, Vigil, Carlos Enrique, additional, Paschka, Peter, additional, Re, Francesca, additional, Di Renzo, Nicola, additional, Lemoli, Roberto M., additional, Mattei, Daniele Giovanni, additional, Ben-Batalla, Isabel, additional, Hellesoy, Monica, additional, Lorens, Katherine, additional, Birkett, Joseph, additional, McPherson, Stuart, additional, Nautiyal, Jaya, additional, Micklem, David, additional, Gabra, Hani, additional, Lorens, James B., additional, Fiedler, Walter, additional, Alvarado, Yesid, additional, and Gjertsen, Bjorn T., additional

Published
2020
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21. Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T‐cell acute lymphoblastic leukemia and lymphoma

Author

Borthakur, Gautam, primary, Martinelli, Giovanni, additional, Raffoux, Emmanuel, additional, Chevallier, Patrice, additional, Chromik, Jörg, additional, Lithio, Andrew, additional, Smith, Claire L., additional, Yuen, Eunice, additional, Oakley, Gerard Joseph, additional, Benhadji, Karim A., additional, and DeAngelo, Daniel J., additional

Published
2020
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22. Durable Responses Observed in Elderly AML Patients Unfit for Intensive Chemotherapy with First-in Class Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with LDAC: Phase II Open-Label Study

Author

Loges, Sonja, primary, Heuser, Michael, additional, Chromik, Jörg, additional, Vigil, Carlos Enrique, additional, Paschka, Peter, additional, Re, Francesca, additional, Di Renzo, Nicola, additional, Lemoli, Roberto Massimo, additional, Mattei, Daniele Giovanni, additional, Ben Batalla, Isabel, additional, Hellesoy, Monica, additional, Micklem, David, additional, Holt, Robert J., additional, Lorens, James B., additional, Shoaib, Muhammad, additional, Aly, Hassan, additional, Hanekom, Wouter, additional, Fiedler, Walter, additional, Cortes, Jorge E., additional, and Gjertsen, Bjorn T., additional

Published
2019
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23. First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC or decitabine exerts anti-leukaemic activity in AML patients unfit for intensive chemotherapy: Phase II open-label study.

Author

Loges, Sonja, primary, Heuser, Michael, additional, Chromik, Jörg, additional, Vigil, Carlos Enrique, additional, Paschka, Peter, additional, RE, Francesca, additional, Di Renzo, Nicola, additional, Lemoli, Roberto, additional, Mattei, Daniele, additional, Ben Batalla, Isabel, additional, Hellesøy, Monica, additional, Micklem, David, additional, Holt, Robert J, additional, Lorens, Katherine, additional, Lorens, James B., additional, Shoaib, Muhammad, additional, Aly, Hassan, additional, Fiedler, Walter M., additional, Cortes, Jorge E., additional, and Gjertsen, Bjorn T., additional

Published
2019
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24. Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T‐cell acute lymphoblastic leukemia and lymphoma.

Author

Borthakur, Gautam, Martinelli, Giovanni, Raffoux, Emmanuel, Chevallier, Patrice, Chromik, Jörg, Lithio, Andrew, Smith, Claire L., Yuen, Eunice, Oakley, Gerard Joseph, Benhadji, Karim A., and DeAngelo, Daniel J.

Subjects
LYMPHOBLASTIC leukemia, ACUTE leukemia, NOTCH proteins, DEXAMETHASONE, GASTROINTESTINAL hemorrhage
Abstract

Background: Deregulated Notch signaling is implicated in T‐cell acute lymphoblastic leukemia (T‐ALL)/T‐cell lymphoblastic lymphoma (T‐LBL). Crenigacestat (LY3039478) prevents cleavage of Notch proteins and may benefit patients with relapsed/refractory T‐ALL/T‐LBL. Methods: JJCB was a multicenter, nonrandomized, open‐label, dose‐escalation, phase 1 study in adult patients with relapsed/refractory T‐ALL/T‐LBL. Eligible patients received Crenigacestat orally 3 times per week plus dexamethasone at 24 mg twice daily on days 1 to 5 every other week in a 28‐day cycle. The starting level of Crenigacestat was 50 mg, and dose escalation was performed with a modified 3+3 scheme for the estimation of dose‐limiting toxicity (DLT) at the recommended dose level. Results: In total, 36 patients with T‐ALL (n = 31 [86.1%]) or T‐LBL (n = 5 [13.9%]) were treated with Crenigacestat and dexamethasone. Six patients (16.7%) experienced DLTs: 2 of 12 (16.7%) in the 75‐mg cohort (grade 4 gastrointestinal hemorrhage and grade 3 nausea, vomiting, and diarrhea), 1 of 15 (6.7%) in the 100‐mg cohort (grade 3 diarrhea), and 3 of 3 (100%) in the 125‐mg cohort (grade 3 diarrhea, nausea, and vomiting). The maximum tolerated dosewas 75 mg plus 24 mg of dexamethasone daily on days 1 to 5. Twenty‐eight patients (77.8%) experienced 1 or more treatment‐emergent adverse events related to the study treatment. The best overall response was a confirmed response, with 1 patient (2.8%) having a duration of response of 10.51 months. Six patients (16.7%) achieved stable disease, and 12 patients (33.3%) experienced progressive disease. The remaining 17 patients (47.2%) were not evaluable. The median event‐free survival was 1.18 months (95% confidence interval, 0.76‐2.14 months) among all groups. A pharmacodynamic analysis showed decreased plasma amyloid β levels. Conclusions: Crenigacestat demonstrated limited clinical activity at the recommended dose in adult patients with relapsed/refractory T‐ALL/T‐LBL. This report describes the clinical activity of a highly potent and selective Notch inhibitor, Crenigacestat, in combination with dexamethasone in adult patients with relapsed/refractory T‐cell acute lymphoblastic leukemia (T‐ALL)/T‐cell lymphoblastic lymphoma (‐LBL). In this study, the recommended phase 2 dose of 75 mg of Crenigacestat 3 times per week is established for patients with T‐ALL/T‐LBL in combination with dexamethasone. [ABSTRACT FROM AUTHOR]

Published
2021
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25. Erythropoietic cellular analyses in luspatercept-treated lower-risk myelodysplastic syndromes (MDS): Phase 2 PACE-MDS study.

Author

Platzbecker, Uwe, primary, Giagounidis, Aristoteles, additional, Kiewe, Philipp M., additional, Germing, Ulrich, additional, Gotze, Katharina S., additional, Mayer, Karin, additional, Radsak, Markus, additional, Wolff, Thomas, additional, Chromik, Jörg, additional, Reynolds, Joseph, additional, Barron, Carolyn, additional, Rovaldi, Chris, additional, Suragani, Rajasekhar NVS, additional, Zhang, Xiaosha, additional, Laadem, Abderrahmane, additional, Linde, Peter G., additional, Sherman, Matthew L., additional, and Oelschlägel, Uta, additional

Published
2018
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26. Analysis of anti-leukemic activity, predictive biomarker candidates, immune activation and pharmakodynamics in R/R AML and MDS in response to treatment with bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a phase II open-label, multi-centre study.

Author

Gjertsen, Bjorn T., primary, Hellesøy, Monica, additional, Reikvam, Håkon, additional, Kittang, Astrid Olsnes, additional, Micklem, David, additional, Brown, Anthony, additional, Lorens, James, additional, Kebenko, Maxim, additional, Janning, Melanie, additional, Binder, Mascha, additional, Fiedler, Walter M., additional, Cortes, Jorge E., additional, Heuser, Michael, additional, Chromik, Jörg, additional, Paschka, Peter, additional, Vigil, Carlos Enrique, additional, and Loges, Sonja, additional

Published
2018
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27. The immunomodulatory activity of bemcentinib (BGB324): A first-in-class selective oral AXL inhibitor in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.

Author

Loges, Sonja, primary, Gjertsen, Björn Tore, additional, Heuser, Michael, additional, Chromik, Jörg, additional, Vigil, Carlos Enrique, additional, Paschka, Peter, additional, Ben-Batalla, I, additional, Akyüz, Nuray, additional, Micklem, David, additional, Brown, Anthony, additional, Lorens, James, additional, Kebenko, Maxim, additional, Janning, Melanie, additional, Binder, Mascha, additional, Fiedler, Walter M., additional, and Cortes, Jorge E., additional

Published
2018
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28. Luspatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes (PACE-MDS): a multicentre, open-label phase 2 dose-finding study with long-term extension study

Author

Platzbecker, Uwe, primary, Germing, Ulrich, additional, Götze, Katharina S, additional, Kiewe, Philipp, additional, Mayer, Karin, additional, Chromik, Jörg, additional, Radsak, Markus, additional, Wolff, Thomas, additional, Zhang, Xiaosha, additional, Laadem, Abderrahmane, additional, Sherman, Matthew L, additional, Attie, Kenneth M, additional, and Giagounidis, Aristoteles, additional

Published
2017
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29. Axl blockade in vitro and in patients with high-risk MDS by the small molecule inhibitor BGB324.

Author

Loges, Sonja, primary, Ben Batalla, Isabel, additional, Heuser, Michael, additional, Berenbrok, Nikolas, additional, Schroeder, Thomas, additional, Geyh, Stefanie, additional, Micklem, David, additional, Chromik, Jörg, additional, Kebenko, Maxim, additional, Fiedler, Walter M., additional, Yule, Murray, additional, Cortes, Jorge E., additional, and Gjertsen, Bjorn T., additional

Published
2017
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30. BGB324, an Orally Available Selective Axl Inhibitor Exerts Anti-Leukemic Activity in the First-in-Patient Trial BGBC003 and Induces Unique Changes in Biomarker Profiles

Author

Sonja, Loges, primary, Gjertsen, Bjorn T., additional, Heuser, Michael, additional, Chromik, Jörg, additional, Ben Batalla, Isabel, additional, Akyüz, Nuray, additional, Micklem, David, additional, Brown, Anthony, additional, Lorens, Jim, additional, Kebenko, Maxim, additional, Janning, Melanie, additional, Binder, Mascha, additional, Fiedler, Walter, additional, and Cortes, Jorge E., additional

Published
2016
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32. Single Cell Signaling Pharmacodynamics in a Phase 1b Trial of the Axl Inhibitor BGB324 in Acute Myeloid Leukemia

Author

Hellesøy, Monica, primary, Gullaksen, Stein-Erik, additional, Tislevoll, Benedicte Sjo, additional, Fagerholt, Oda Helen Eck, additional, Reikvam, Hakon, additional, Loges, Sonja, additional, Cortes, Jorge, additional, Heuser, Michael, additional, Chromik, Jörg, additional, Skavland, Jørn, additional, Sulen, André, additional, Bruserud, Øystein, additional, Lorens, Jim, additional, Gausdal, Gro, additional, Micklem, David, additional, and Gjertsen, Bjorn T., additional

Published
2016
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33. Analysis of the Impact of Body Mass Index (BMI) on the Durability of Response in Patients with Aplastic Anemia Treated with Weight-Adjusted Horse Anti-Thymocyte Globulin (hATG)

Author

Walter, Jeanette, Rolles, Benjamin, Schumacher, Yannic, Theis, Frauke, Hansmann, Leo, Heudobler, Daniel, Radsak, Markus, Heuser, Michael, Georgi, Julia-Annabell, Chromik, Jörg, Drexler, Beatrice, Schubert, Jörg, Kricheldorf, Kim, Isfort, Susanne, Panse, Jens, Brümmendorf, Tim H., and Beier, Fabian

Abstract

Introduction: Immunosuppressive therapy (IST) with anti-thymocyte globulin (ATG), cyclosporine A (CsA) and Eltrombopag (Epag) has recently been established as standard of care in adult patients (pts.) with severe (sAA) or very severe (vsAA) aplastic anemia > 40-50 years or ineligible for transplant for other reasons. ATG works via immunosuppressive properties including T-cell depletion and induction of immune tolerance. Horse ATG (hATG) is applied for 4 days with 40 mg/kg/day based on the patient's currentbody weight. Thus, obese pts., defined by a body mass index (BMI) ≥ 30, receive higher absolute hATG dosages than non-obese pts. (BMI < 30). To date, it is unknown whether increased hATG dosages in obese pts. might have beneficial or adverse effects on AA treatment. To address the role of obesity in AA, we investigated (1) the prevalence of obesity in 334 pts. with (suspected) AA and (2) compared the overall survival (OS) and response of 89 obese and non-obese AA pts. to the treatment with hATG/CsA ±Epag.

Published
2023
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34. Real-Life Data of Cyclosporine (CsA) Tapering in Patients with Very/ Severe Aplastic Anemia (v/sAA) Treated with Horse Anti-Thymocyte Globulin (hATG/CsA) Suggest Higher Risk of AA Relapse at Cyclosporine Plasma Levels below 100 Nanogram per Milliliter

Author

Walter, Jeanette, Kricheldorf, Kim, Schumacher, Yannic, Isfort, Susanne, Chromik, Jörg, Drexler, Beatrice, Theis, Frauke, Panse, Jens, Brümmendorf, Tim H., and Beier, Fabian

Abstract

Introduction: Aplastic anemia (AA) is an acquired bone marrow failure syndrome (BMFS) mediated by autoreactive T-cells. In adults with severe (s) or very severe (vs) AA >40-50 years or ineligible for transplant for other reasons immunosuppressive therapy (IST) with anti-thymocyte globulin (ATG), cyclosporine A (CsA) and Eltrombopag (Epag) has recently become the actual standard of care. With CsA treatment maintained for 6 to 24 months followed by CsA tapering hematologic response is achieved in 60-70 % of AA patients (pts.), while 30-40 % are primary refractory. Approximately 40% of pts. relapse during CsA tapering and most relapsed AA pts. remain CsA dependent. In vitro data indicate a dose dependent inhibition of T cell activity induced by CsA, suggesting the presence of a therapeutic CsA threshold around 100 ng/mL (Flores et al. Front Immunol 2019). Pts. with CsA related side effects such as renal insufficiency would benefit from an established lowest efficient CsA plasma level preventing relapse and reducing CsA related toxicity. As data about correlation of CsA plasma levels and the occurrence of relapse during tapering are sparse, we analyzed data from our registries including CsA plasma levels of 20 s/vsAA pts. with and without relapse during CsA tapering after treatment with horse ATG/CsA.

Published
2023
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35. Final Analysis of the Dose Escalation, Expansion and Biomarker Correlations in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS

Author

Loges, Sonja, Heuser, Michael, Chromik, Joerg, Vigil, Carlos E, Paschka, Peter, Ben-Batalla, Isabel, Akyüz, Nuray, Micklem, David, Holt, Robert, Brown, Anthony, Lorens, James, Yule, Murray, Kebenko, Maxim, Janning, Melanie, Binder, Mascha, Fiedler, Walter, Cortes, Jorge E., and Gjertsen, Bjorn

Published
2018
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36. Selinexor, ARA-C and Idarubicin: An Effective and Tolerable Combination in Patients with Relapsed/Refractory AML: A Multicenter Phase II Study

Author

Fiedler, Walter, primary, Chromik, Jörg, additional, Kebenko, Maxim, additional, Thol, Felicitas, additional, Trummer, Arne, additional, Schünemann, Chirstoph, additional, Brandts, Christian H., additional, Köhler, Anne, additional, Schlipfenbacher, Vera, additional, Bokemeyer, Carsten, additional, Theile, Susann, additional, Kranich, Anne L., additional, and Heuser, Michael, additional

Published
2015
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39. Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in Patients with Low-Intermediate Risk Myelodysplastic Syndromes (MDS): Long-Term Results from Phase 2 PACE-MDS Study

Author

Platzbecker, Uwe, Germing, Ulrich, Götze, Katharina, Kiewe, Philipp, Wolff, Thomas, Mayer, Karin, Chromik, Joerg, Radsak, Markus, Donovan, Eileen, Wilson, Dawn M., Zhang, Xiaosha, Laadem, Abderrahmane, Sherman, Matthew L., Attie, Kenneth M., and Giagounidis, Aristoteles

Published
2016
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42. Results from a First-in-Human Phase I Study of Siremadlin (HDM201) in Patients with Advanced Wild-Type TP53 Solid Tumors and Acute Leukemia.

Author

Stein EM, DeAngelo DJ, Chromik J, Chatterjee M, Bauer S, Lin CC, Suarez C, de Vos F, Steeghs N, Cassier PA, Tai D, Kiladjian JJ, Yamamoto N, Mous R, Esteve J, Minami H, Ferretti S, Guerreiro N, Meille C, Radhakrishnan R, Pereira B, Mariconti L, Halilovic E, Fabre C, and Carpio C

Subjects
Dose-Response Relationship, Drug, Humans, Imidazoles, Maximum Tolerated Dose, Pyrimidines, Pyrroles, Tumor Suppressor Protein p53 genetics, Hematologic Neoplasms drug therapy, Hematologic Neoplasms genetics, Leukemia, Myeloid, Acute drug therapy, Leukemia, Myeloid, Acute genetics, Neoplasms drug therapy
Abstract

Purpose: This phase I, dose-escalation study investigated the recommended dose for expansion (RDE) of siremadlin, a p53-MDM2 inhibitor, in patients with wild-type TP53 advanced solid or hematologic cancers., Patients and Methods: Initial dosing regimens were: 1A (day 1; 21-day cycle; dose 12.5-350 mg) and 2A (days 1-14; 28-day cycle; dose 1-20 mg). Alternative regimens included 1B (days 1 and 8; 28-day cycle) and 2C (days 1-7; 28-day cycle). The primary endpoint was incidence of dose-limiting toxicities (DLT) during cycle 1., Results: Overall, 115 patients with solid tumors and 93 with hematologic malignancies received treatment. DLTs occurred in 8/92 patients with solid tumors and 10/53 patients with hematologic malignancies. In solid tumors, an RDE of 120 mg was defined in 1B. In hematologic tumors, RDEs were defined in 1A: 250 mg, 1B: 120 mg, and 2C: 45 mg. More patients with hematologic malignancies compared with solid tumors experienced grade 3/4 treatment-related adverse events (71% vs. 45%), most commonly resulting from myelosuppression. These were more frequent and severe in patients with hematologic malignancies; 22 patients exhibited tumor lysis syndrome. Overall response rates at the RDEs were 10.3% [95% confidence interval (CI), 2.2-27.4] in solid tumors and 4.2% (95% CI, 0.1-21.1), 20% (95% CI, 4.3-48.1), and 22.2% (95% CI, 8.6-42.3) in acute myeloid leukemia (AML) in 1B, 1A, and 2C, respectively., Conclusions: A common safety profile was identified and preliminary activity was noted, particularly in AML. Comprehensive investigation of dosing regimens yielded recommended doses/regimens for future combination studies., (©2021 The Authors; Published by the American Association for Cancer Research.)

Published
2022
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