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1. Efficacy of Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Richter Transformation: Results from the Phase 1/2 BRUIN Study

Author

Wierda, William G., Lewis, David John, Ghia, Paolo, Shah, Nirav N., Coombs, Catherine C., Cheah, Chan Y., Lamanna, Nicole, Rhodes, Joanna M., Hoffmann, Marc, Ma, Shuo, Eyre, Toby A., Munir, Talha, Patel, Manish R., Alencar, Alvaro J., Tam, Constantine S., Seymour, John F., Jurczak, Wojciech, Lech-Marańda, Ewa, Roeker, Lindsey E., Thompson, Philip A., Abada, Paolo B., Wang, Chunxiao, Nair, Binoj, Liu, Hui, Tsai, Donald E., and Mato, Anthony R.

Published
2022
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2. Efficacy of Pirtobrutinib in Covalent BTK-Inhibitor Pre-Treated Relapsed / Refractory CLL/SLL: Additional Patients and Extended Follow-up from the Phase 1/2 BRUIN Study

Author

Mato, Anthony R., Woyach, Jennifer A., Brown, Jennifer R., Ghia, Paolo, Patel, Krish, Eyre, Toby A., Munir, Talha, Lech-Marańda, Ewa, Lamanna, Nicole, Tam, Constantine S., Seymour, John F., Shah, Nirav N., Coombs, Catherine C., Ujjani, Chaitra S., Patel, Manish R., Fakhri, Bita, Cheah, Chan Y., Alencar, Alvaro J., Cohen, Jonathon B., Gerson, James N., Flinn, Ian W., Ma, Shuo, Jagadeesh, Deepa, Rhodes, Joanna M., Hernandez-Ilizaliturri, Francisco, Zinzani, Pier Luigi, Balbas, Minna, Nair, Binoj, Abada, Paolo B., Wang, Chunxiao, Wang, Denise, Tsai, Donald E., Wierda, William G., and Jurczak, Wojciech

Published
2022
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3. Differences in Clinical Course and Management of Sars-CoV2 Infection in Patients with Chronic Lymphocytic Leukemia between the Sequential Pandemic Phases: An Eric Study

Author

Visentin, Andrea, Scarfò, Lydia, Chatzikonstantinou, Thomas, Kapetanakis, Anargyros, Demosthenous, Christos, Karakatsoulis, Georgios, Andres, Martin, Antic, Darko, Allsup, David, Baile, Mónica, Bron, Dominique, Capasso, Antonella, Catherwood, Mark, Collado, Rosa, Cordoba, Raul, Cuéllar-García, Carolina, Delgado, Julio, Dimou, Maria, Doubek, Michael, De Paoli, Lorenzo, De Paolis, Maria Rosaria, Del Poeta, Giovanni, Efstathopoulou, Maria, Shimaa, El-Ashwah, Enrico, Alicia, Farina, Lucia, Ferrari, Angela, Foglietta, Myriam, Furstenau, Moritz, Garcia-Marco, Jose A., Gentile, Massimo, Gimeno, Eva, Maria, Gomes da Silva, Gutwein, Odit, Hakobyan, Yervand, Herishanu, Yair, Hernandez, jose Angel, Herold, Tobias, Iyengar, Sunil, Itchaki, Gilad, Jaksic, Ozren, Janssens, Ann, Kalashnikova, Olga, Kalicinska, Elzbieta, Kater, Arnon P., Kersting, Sabina, Labrador, Jorge, Lad, Deepesh, Laurenti, Luca, Levin, Mark-David, Lista, Enrico, Malerba, Lara, Marasca, Roberto, Marchetti, Monia, Marquet Palomanes, Juan, Mattsson, Mattias, Mauro, Francesca Romana, Mayor-Bastida, Carlota, Morawska, Marta, Motta, Marina, Munir, Talha, Murru, Roberta, Milosevic, Ivana, Miras Calvo, Fatima, Niemann, Carsten Utoft, Olivieri, Jacopo, Orsucci, Lorella, Papaioannou, Maria, Pavlovsky, Miguel Arturo, Piskunova, Inga S., Pocali, Barbara, Popov, Viola Maria, Quaglia, Francesca Maria, Quaresmini, Giulia, Raa, Doreen te, Reda, Gianluigi, Rigolin, Gian Matteo, Ruchlemer, Rosa, Shrestha, Amit, Šimkovič, Martin, Špaček, Martin, Sportoletti, Paolo, Stanca Ciocan, Oana, Tadmor, Tamar, Vandenberghe, Elisabeth, Varettoni, Marzia, Vitale, Candida, Van Der Spek, Ellen, Van Gelder, Michel, Wasik-Szczepanek, Ewa, Yáñez, Lucrecia, Yassin, Mohamed A, Coscia, Marta, Eichhorst, Barbara, Rambaldi, Alessandro, Stavroyianni, Niki, Trentin, Livio, Stamatopoulos, Kostas, and Ghia, Paolo

Published
2022
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4. Efficacy of Pirtobrutinib in Covalent BTK-Inhibitor Pre-Treated Relapsed / Refractory Mantle Cell Lymphoma: Additional Patients and Extended Follow-up from the Phase 1/2 BRUIN Study

Author

Wang, Michael L., Shah, Nirav N., Jurczak, Wojciech, Zinzani, Pier Luigi, Eyre, Toby A., Cheah, Chan Y., Ujjani, Chaitra S., Koh, Youngil, Izutsu, Koji, Gerson, James N., Flinn, Ian W., Tessoulin, Benoit, Alencar, Alvaro J., Ma, Shuo, Lech-Marańda, Ewa, Rhodes, Joanna M., Patel, Krish, Woyach, Jennifer A., Lamanna, Nicole, Wang, Yucai, Tam, Constantine S., Seymour, John F., Munir, Talha, Nagai, Hirokazu, Hernandez-Ilizaliturri, Francisco, Kumar, Anita, Zelenetz, Andrew D., Jain, Preetesh, Nair, Binoj, Tsai, Donald E., Balbas, Minna, Walgren, Richard A., Abada, Paolo B., Wang, Chunxiao, Zhao, Junjie, and Mato, Anthony R.

Published
2022
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5. Efficacy of Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed / Refractory Waldenström Macroglobulinemia: Results from the Phase 1/2 BRUIN Study

Author

Palomba, M.Lia, Patel, Manish R., Eyre, Toby A., Jurczak, Wojciech, Lewis, David John, Gastinne, Thomas, Ma, Shuo, Cohen, Jonathon B., Patel, Krish, Brown, Jennifer R., Scarfò, Lydia, Munir, Talha, Lech-Marańda, Ewa, Hoffmann, Marc, Ujjani, Chaitra S., Fakhri, Bita, Wang, Michael L., Izutsu, Koji, Nagai, Hirokazu, Tam, Constantine S., Seymour, John F., Rhodes, Joanna M., Vose, Julie M., McKinney, Matthew, Gerson, James N., Barve, Minal A., Kuss, Bryone J., Koh, Youngil, Gao, Wei, Ruppert, Amy S., Walgren, Richard A., Tsai, Donald E., Nair, Binoj, Bao, Katherine, Mato, Anthony R., and Cheah, Chan Y.

Published
2022
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6. Efficacy of Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Richter Transformation: Results from the Phase 1/2 BRUIN Study

Author

Wierda, William G., Lewis, David John, Ghia, Paolo, Shah, Nirav N., Coombs, Catherine C., Cheah, Chan Y., Lamanna, Nicole, Rhodes, Joanna M., Hoffmann, Marc, Ma, Shuo, Eyre, Toby A., Munir, Talha, Patel, Manish R., Alencar, Alvaro J., Tam, Constantine S., Seymour, John F., Jurczak, Wojciech, Lech-Marańda, Ewa, Roeker, Lindsey E., Thompson, Philip A., Abada, Paolo B., Wang, Chunxiao, Nair, Binoj, Liu, Hui, Tsai, Donald E., and Mato, Anthony R.

Published
2022
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7. Efficacy of Pirtobrutinib in Covalent BTK-Inhibitor Pre-Treated Relapsed / Refractory Mantle Cell Lymphoma: Additional Patients and Extended Follow-up from the Phase 1/2 BRUIN Study

Author

Wang, Michael L., Shah, Nirav N., Jurczak, Wojciech, Zinzani, Pier Luigi, Eyre, Toby A., Cheah, Chan Y., Ujjani, Chaitra S., Koh, Youngil, Izutsu, Koji, Gerson, James N., Flinn, Ian W., Tessoulin, Benoit, Alencar, Alvaro J., Ma, Shuo, Lech-Marańda, Ewa, Rhodes, Joanna M., Patel, Krish, Woyach, Jennifer A., Lamanna, Nicole, Wang, Yucai, Tam, Constantine S., Seymour, John F., Munir, Talha, Nagai, Hirokazu, Hernandez-Ilizaliturri, Francisco, Kumar, Anita, Zelenetz, Andrew D., Jain, Preetesh, Nair, Binoj, Tsai, Donald E., Balbas, Minna, Walgren, Richard A., Abada, Paolo B., Wang, Chunxiao, Zhao, Junjie, and Mato, Anthony R.

Published
2022
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8. Efficacy of Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed / Refractory Waldenström Macroglobulinemia: Results from the Phase 1/2 BRUIN Study

Author

Palomba, M.Lia, Patel, Manish R., Eyre, Toby A., Jurczak, Wojciech, Lewis, David John, Gastinne, Thomas, Ma, Shuo, Cohen, Jonathon B., Patel, Krish, Brown, Jennifer R., Scarfò, Lydia, Munir, Talha, Lech-Marańda, Ewa, Hoffmann, Marc, Ujjani, Chaitra S., Fakhri, Bita, Wang, Michael L., Izutsu, Koji, Nagai, Hirokazu, Tam, Constantine S., Seymour, John F., Rhodes, Joanna M., Vose, Julie M., McKinney, Matthew, Gerson, James N., Barve, Minal A., Kuss, Bryone J., Koh, Youngil, Gao, Wei, Ruppert, Amy S., Walgren, Richard A., Tsai, Donald E., Nair, Binoj, Bao, Katherine, Mato, Anthony R., and Cheah, Chan Y.

Published
2022
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9. Thrombotic and Bleeding Complications in Patients with Chronic Lymphocytic Leukemia and Severe COVID-19: A Study of Eric, the European Research Initiative on CLL

Author

Antic, Darko, Milic, Natasa, Chatzikonstantinou, Thomas, Scarfò, Lydia, Otasevic, Vladimir, Rajovic, Nina, Allsup, David, Cabrero, Alejandro Alonso, Andres, Martin, Baile Gonzales, Monica, Capasso, Antonella, Collado, Rosa, Cordoba, Raul, Cuéllar-García, Carolina, Correa, Juan Gonzalo, De Paoli, Lorenzo, De Paolis, Maria Rosaria, Del Poeta, Giovanni, Dimou, Maria, Doubek, Michael, Efstathopoulou, Maria, El-Ashwah, Shaimaa, Enrico, Alicia, Espinet, Blanca, Farina, Lucia, Ferrari, Angela, Foglietta, Myriam, Lopez-Garcia, Alberto, Garcia-Marco, Jose A., García-Serra, Rocío, Gentile, Massimo, Gimeno, Eva, Gomes da Silva, Maria, Gutwein, Odit, Hakobyan, Yervand, Herishanu, Yair, Hernández-Rivas, José Ángel, Herold, Tobias, Itchaki, Gilad, Jaksic, Ozren, Janssens, Ann, Kalashnikova, Оlga B., Kalicińska, Elżbieta, Kater, Arnon P., Kersting, Sabina, Koren-Michowitz, Maya, Gomez, Jorge Labrador, Lad, Deepesh, Laurenti, Luca, Fresa, Alberto, Levin, Mark-David, Mayor Bastida, Carlota, Malerba, Lara, Marasca, Roberto, Marchetti, Monia, Marquet, Juan, Mihaljevic, Biljana, Milosevic, Ivana, Mirás, Fatima, Morawska, Marta, Motta, Marina, Munir, Talha, Murru, Roberta, Nunes, Raquel, Olivieri, Jacopo, Pavlovsky, Miguel Arturo, Piskunova, Inga S., Popov, Viola Maria, Quaglia, Francesca Maria, Quaresmini, Giulia, Reda, Gianluigi, Rigolin, Gian Matteo, Shrestha, Amit, Šimkovič, Martin, Smirnova, Svetlana, Špaček, Martin, Sportoletti, Paolo, Stanca, Oana, Stavroyianni, Niki, Te Raa, Doreen, Tomic, Kristina, Tonino, Sanne, Trentin, Livio, Van Der Spek, Ellen, van Gelder, Michel, Varettoni, Marzia, Visentin, Andrea, Vitale, Candida, Vukovic, Vojin, Wasik-Szczepanek, Ewa, Wróbel, Tomasz, Yanez San Segundo, Lucrecia, Yassin, Mohamed A, Coscia, Marta, Rambaldi, Alessandro, Montserrat, Emili, Foà, Robin, Cuneo, Antonio, Carrier, Marc, Ghia, Paolo, and Stamatopoulos, Kostas

Published
2022
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10. Molecular Characterization of Clinical Response and Relapse in Patients with IDH1m ND-AML Treated with Ivo+AZA in the AGILE Study

Author

Döhner, Hartmut, Marchione, Dylan M., Choe, Sung, Montesinos, Pau, Recher, Christian, Vives, Susana, Zarzycka, Ewa, Wang, Jianxiang, Cerchione, Claudio, Heuser, Michael, Calado, Rodrigo T., Schuh, Andre C., Yeh, Su-Peng, De La Fuente, Adolfo, Hui, Jianan, Patel, Prapti, Gianolio, Diego A., Daigle, Scott R., DiNardo, Courtney D., and De Botton, Stephane

Published
2022
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11. Safety and Tolerability of Pirtobrutinib Monotherapy in Patients with B-Cell Malignancies Who Were Previously Intolerant to a Covalent BTK Inhibitor: Results from the Phase 1/2 BRUIN Study

Author

Shah, Nirav N., Wang, Michael L., Brown, Jennifer R., Patel, Krish, Woyach, Jennifer A., Wierda, William G., Ujjani, Chaitra S., Eyre, Toby A., Zinzani, Pier Luigi, Alencar, Alvaro J., Gastinne, Thomas, Ghia, Paolo, Lamanna, Nicole, Hoffmann, Marc, Patel, Manish R., Flinn, Ian W., Gerson, James N., Ma, Shuo, Coombs, Catherine C., Cheah, Chan Y., Lech-Marańda, Ewa, Fakhri, Bita, Kim, Won-Seog, Barve, Minal A., Cohen, Jonathon B., Jurczak, Wojciech, Munir, Talha, Thompson, Meghan C., Roeker, Lindsey E., Bao, Katherine, Cangemi, Nicholas A., Kherani, Jennifer F., Walgren, Richard A., Han, Hongmei, Ruppert, Amy S., and Mato, Anthony R.

Published
2022
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12. Thrombotic and Bleeding Complications in Patients with Chronic Lymphocytic Leukemia and Severe COVID-19: A Study of Eric, the European Research Initiative on CLL

Author

Antic, Darko, Milic, Natasa, Chatzikonstantinou, Thomas, Scarfò, Lydia, Otasevic, Vladimir, Rajovic, Nina, Allsup, David, Cabrero, Alejandro Alonso, Andres, Martin, Baile Gonzales, Monica, Capasso, Antonella, Collado, Rosa, Cordoba, Raul, Cuéllar-García, Carolina, Correa, Juan Gonzalo, De Paoli, Lorenzo, De Paolis, Maria Rosaria, Del Poeta, Giovanni, Dimou, Maria, Doubek, Michael, Efstathopoulou, Maria, El-Ashwah, Shaimaa, Enrico, Alicia, Espinet, Blanca, Farina, Lucia, Ferrari, Angela, Foglietta, Myriam, Lopez-Garcia, Alberto, Garcia-Marco, Jose A., García-Serra, Rocío, Gentile, Massimo, Gimeno, Eva, Gomes da Silva, Maria, Gutwein, Odit, Hakobyan, Yervand, Herishanu, Yair, Hernández-Rivas, José Ángel, Herold, Tobias, Itchaki, Gilad, Jaksic, Ozren, Janssens, Ann, Kalashnikova, Оlga B., Kalicińska, Elżbieta, Kater, Arnon P., Kersting, Sabina, Koren-Michowitz, Maya, Gomez, Jorge Labrador, Lad, Deepesh, Laurenti, Luca, Fresa, Alberto, Levin, Mark-David, Mayor Bastida, Carlota, Malerba, Lara, Marasca, Roberto, Marchetti, Monia, Marquet, Juan, Mihaljevic, Biljana, Milosevic, Ivana, Mirás, Fatima, Morawska, Marta, Motta, Marina, Munir, Talha, Murru, Roberta, Nunes, Raquel, Olivieri, Jacopo, Pavlovsky, Miguel Arturo, Piskunova, Inga S., Popov, Viola Maria, Quaglia, Francesca Maria, Quaresmini, Giulia, Reda, Gianluigi, Rigolin, Gian Matteo, Shrestha, Amit, Šimkovič, Martin, Smirnova, Svetlana, Špaček, Martin, Sportoletti, Paolo, Stanca, Oana, Stavroyianni, Niki, Te Raa, Doreen, Tomic, Kristina, Tonino, Sanne, Trentin, Livio, Van Der Spek, Ellen, van Gelder, Michel, Varettoni, Marzia, Visentin, Andrea, Vitale, Candida, Vukovic, Vojin, Wasik-Szczepanek, Ewa, Wróbel, Tomasz, Yanez San Segundo, Lucrecia, Yassin, Mohamed A, Coscia, Marta, Rambaldi, Alessandro, Montserrat, Emili, Foà, Robin, Cuneo, Antonio, Carrier, Marc, Ghia, Paolo, and Stamatopoulos, Kostas

Published
2022
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13. Differences in Clinical Course and Management of Sars-CoV2 Infection in Patients with Chronic Lymphocytic Leukemia between the Sequential Pandemic Phases: An Eric Study

Author

Visentin, Andrea, Scarfò, Lydia, Chatzikonstantinou, Thomas, Kapetanakis, Anargyros, Demosthenous, Christos, Karakatsoulis, Georgios, Andres, Martin, Antic, Darko, Allsup, David, Baile, Mónica, Bron, Dominique, Capasso, Antonella, Catherwood, Mark, Collado, Rosa, Cordoba, Raul, Cuéllar-García, Carolina, Delgado, Julio, Dimou, Maria, Doubek, Michael, De Paoli, Lorenzo, De Paolis, Maria Rosaria, Del Poeta, Giovanni, Efstathopoulou, Maria, Shimaa, El-Ashwah, Enrico, Alicia, Farina, Lucia, Ferrari, Angela, Foglietta, Myriam, Furstenau, Moritz, Garcia-Marco, Jose A., Gentile, Massimo, Gimeno, Eva, Maria, Gomes da Silva, Gutwein, Odit, Hakobyan, Yervand, Herishanu, Yair, Hernandez, jose Angel, Herold, Tobias, Iyengar, Sunil, Itchaki, Gilad, Jaksic, Ozren, Janssens, Ann, Kalashnikova, Olga, Kalicinska, Elzbieta, Kater, Arnon P., Kersting, Sabina, Labrador, Jorge, Lad, Deepesh, Laurenti, Luca, Levin, Mark-David, Lista, Enrico, Malerba, Lara, Marasca, Roberto, Marchetti, Monia, Marquet Palomanes, Juan, Mattsson, Mattias, Mauro, Francesca Romana, Mayor-Bastida, Carlota, Morawska, Marta, Motta, Marina, Munir, Talha, Murru, Roberta, Milosevic, Ivana, Miras Calvo, Fatima, Niemann, Carsten Utoft, Olivieri, Jacopo, Orsucci, Lorella, Papaioannou, Maria, Pavlovsky, Miguel Arturo, Piskunova, Inga S., Pocali, Barbara, Popov, Viola Maria, Quaglia, Francesca Maria, Quaresmini, Giulia, Raa, Doreen te, Reda, Gianluigi, Rigolin, Gian Matteo, Ruchlemer, Rosa, Shrestha, Amit, Šimkovič, Martin, Špaček, Martin, Sportoletti, Paolo, Stanca Ciocan, Oana, Tadmor, Tamar, Vandenberghe, Elisabeth, Varettoni, Marzia, Vitale, Candida, Van Der Spek, Ellen, Van Gelder, Michel, Wasik-Szczepanek, Ewa, Yáñez, Lucrecia, Yassin, Mohamed A, Coscia, Marta, Eichhorst, Barbara, Rambaldi, Alessandro, Stavroyianni, Niki, Trentin, Livio, Stamatopoulos, Kostas, and Ghia, Paolo

Published
2022
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14. Efficacy of Pirtobrutinib in Covalent BTK-Inhibitor Pre-Treated Relapsed / Refractory CLL/SLL: Additional Patients and Extended Follow-up from the Phase 1/2 BRUIN Study

Author

Mato, Anthony R., Woyach, Jennifer A., Brown, Jennifer R., Ghia, Paolo, Patel, Krish, Eyre, Toby A., Munir, Talha, Lech-Marańda, Ewa, Lamanna, Nicole, Tam, Constantine S., Seymour, John F., Shah, Nirav N., Coombs, Catherine C., Ujjani, Chaitra S., Patel, Manish R., Fakhri, Bita, Cheah, Chan Y., Alencar, Alvaro J., Cohen, Jonathon B., Gerson, James N., Flinn, Ian W., Ma, Shuo, Jagadeesh, Deepa, Rhodes, Joanna M., Hernandez-Ilizaliturri, Francisco, Zinzani, Pier Luigi, Balbas, Minna, Nair, Binoj, Abada, Paolo B., Wang, Chunxiao, Wang, Denise, Tsai, Donald E., Wierda, William G., and Jurczak, Wojciech

Published
2022
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15. Safety and Tolerability of Pirtobrutinib Monotherapy in Patients with B-Cell Malignancies Who Were Previously Intolerant to a Covalent BTK Inhibitor: Results from the Phase 1/2 BRUIN Study

Author

Shah, Nirav N., Wang, Michael L., Brown, Jennifer R., Patel, Krish, Woyach, Jennifer A., Wierda, William G., Ujjani, Chaitra S., Eyre, Toby A., Zinzani, Pier Luigi, Alencar, Alvaro J., Gastinne, Thomas, Ghia, Paolo, Lamanna, Nicole, Hoffmann, Marc, Patel, Manish R., Flinn, Ian W., Gerson, James N., Ma, Shuo, Coombs, Catherine C., Cheah, Chan Y., Lech-Marańda, Ewa, Fakhri, Bita, Kim, Won-Seog, Barve, Minal A., Cohen, Jonathon B., Jurczak, Wojciech, Munir, Talha, Thompson, Meghan C., Roeker, Lindsey E., Bao, Katherine, Cangemi, Nicholas A., Kherani, Jennifer F., Walgren, Richard A., Han, Hongmei, Ruppert, Amy S., and Mato, Anthony R.

Published
2022
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16. Molecular Characterization of Clinical Response and Relapse in Patients with IDH1m ND-AML Treated with Ivo+AZA in the AGILE Study

Author

Döhner, Hartmut, Marchione, Dylan M., Choe, Sung, Montesinos, Pau, Recher, Christian, Vives, Susana, Zarzycka, Ewa, Wang, Jianxiang, Cerchione, Claudio, Heuser, Michael, Calado, Rodrigo T., Schuh, Andre C., Yeh, Su-Peng, De La Fuente, Adolfo, Hui, Jianan, Patel, Prapti, Gianolio, Diego A., Daigle, Scott R., DiNardo, Courtney D., and De Botton, Stephane

Published
2022
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18. A Polish Acute Leukemia Group Prospective Multicenter Clinical Trial to Compare the Efficacy of Two Standard Induction Therapies (DA-90 vs DAC) and Two Standard Salvage Regimens (FLAG-IDA vs CLAG-M) in Acute Myeloid Leukemia (AML) Patients ≤ 60 Years Old (PALG-AML1/2016)

Author

Wierzbowska, Agnieszka, Czyz, Anna, Pluta, Agnieszka, Libura, Marta Antonina, Giebel, Sebastian, Stelmach, Piotr, Czemerska, Magdalena, Krawiec, Kinga, Kopinska, Anna, Wozniczka, Krzysztof, Helbig, Grzegorz, Halka, Janusz, Sobas, Marta Anna, Wróbel, Tomasz, Szczepaniak, Andrzej, Gil, Lidia, Dutka, Magdalena, Bieniaszewska, Maria, Gromek, Tomasz, Hus, Marek, Patkowska, Elzbieta, Watek, Marzena, Lech-Marańda, Ewa, Kopacz, Agnieszka, Dulik, Katarzyna, Holowiecki, Jerzy, Obara, Agata, Cichocka, Edyta, Gawronski, Krzysztof, Mordak-Domagala, Monika, Sukkur, Ameenah, Rustani, Andi, Desai, Pinkal, Samuel, Michael, Mencia Trinchant, Nuria, Lee, Sangmin, Kaner, Justin D., Ritchie, Ellen, Guzman, Monica L., and Roboz, Gail J.

Published
2022
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19. A Polish Acute Leukemia Group Prospective Multicenter Clinical Trial to Compare the Efficacy of Two Standard Induction Therapies (DA-90 vs DAC) and Two Standard Salvage Regimens (FLAG-IDA vs CLAG-M) in Acute Myeloid Leukemia (AML) Patients ≤ 60 Years Old (PALG-AML1/2016)

Author

Wierzbowska, Agnieszka, Czyz, Anna, Pluta, Agnieszka, Libura, Marta Antonina, Giebel, Sebastian, Stelmach, Piotr, Czemerska, Magdalena, Krawiec, Kinga, Kopinska, Anna, Wozniczka, Krzysztof, Helbig, Grzegorz, Halka, Janusz, Sobas, Marta Anna, Wróbel, Tomasz, Szczepaniak, Andrzej, Gil, Lidia, Dutka, Magdalena, Bieniaszewska, Maria, Gromek, Tomasz, Hus, Marek, Patkowska, Elzbieta, Watek, Marzena, Lech-Marańda, Ewa, Kopacz, Agnieszka, Dulik, Katarzyna, Holowiecki, Jerzy, Obara, Agata, Cichocka, Edyta, Gawronski, Krzysztof, Mordak-Domagala, Monika, Sukkur, Ameenah, Rustani, Andi, Desai, Pinkal, Samuel, Michael, Mencia Trinchant, Nuria, Lee, Sangmin, Kaner, Justin D., Ritchie, Ellen, Guzman, Monica L., and Roboz, Gail J.

Published
2022
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21. Prospective Assessment of Measurable Residual Disease Kinetics in Intensively Treated Patients with Acute Myeloid Leukemia - Results of the Polish Adult Leukemia Group PALG-AML1/2016 Study

Author

Wierzbowska, Agnieszka, Pluta, Agnieszka, Czyz, Anna, Libura, Marta Antonina, Giebel, Sebastian, Stelmach, Piotr, Czemerska, Magdalena, Strzałka, Piotr, Kopinska, Anna, Wozniczka, Krzysztof, Helbig, Grzegorz, Wojcik, Karol, Razny, Malgorzata, Sobas, Marta Anna, Wróbel, Tomasz, Szczepaniak, Andrzej, Gil, Lidia, Dutka, Magdalena, Bieniaszewska, Maria, Gromek, Tomasz, Hus, Marek, Cichocka, Edyta, Halka, Janusz, Patkowska, Elzbieta, Watek, Marzena, Wozniak, Jolanta, Lech-Marańda, Ewa, Kopacz, Agnieszka, Dulik, Katarzyna, Holowiecki, Jerzy, Soin, Michal, Mikulski, Damian, Perdas, Ewelina, Fendler, Wojciech, Sukkur, Ameenah, Rustani, Andi, Mencia Trinchant, Nuria, Desai, Pinkal, Lee, Sangmin, Samuel, Michael, Kaner, Justin D., Ritchie, Ellen, Guzman, Monica L., and Roboz, Gail J.

Published
2022
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22. Prospective Assessment of Measurable Residual Disease Kinetics in Intensively Treated Patients with Acute Myeloid Leukemia - Results of the Polish Adult Leukemia Group PALG-AML1/2016 Study

Author

Wierzbowska, Agnieszka, Pluta, Agnieszka, Czyz, Anna, Libura, Marta Antonina, Giebel, Sebastian, Stelmach, Piotr, Czemerska, Magdalena, Strzałka, Piotr, Kopinska, Anna, Wozniczka, Krzysztof, Helbig, Grzegorz, Wojcik, Karol, Razny, Malgorzata, Sobas, Marta Anna, Wróbel, Tomasz, Szczepaniak, Andrzej, Gil, Lidia, Dutka, Magdalena, Bieniaszewska, Maria, Gromek, Tomasz, Hus, Marek, Cichocka, Edyta, Halka, Janusz, Patkowska, Elzbieta, Watek, Marzena, Wozniak, Jolanta, Lech-Marańda, Ewa, Kopacz, Agnieszka, Dulik, Katarzyna, Holowiecki, Jerzy, Soin, Michal, Mikulski, Damian, Perdas, Ewelina, Fendler, Wojciech, Sukkur, Ameenah, Rustani, Andi, Mencia Trinchant, Nuria, Desai, Pinkal, Lee, Sangmin, Samuel, Michael, Kaner, Justin D., Ritchie, Ellen, Guzman, Monica L., and Roboz, Gail J.

Published
2022
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23. Preclinical and Clinical Evidence for Erythroid-Stimulating Activity of RVU120 CDK8/19 Inhibitor in AML and MDS

Author

Angelosanto, Noemi, Marańda, Ewa Lech, Zaucha, Jan Maciej, Abboud, Camille N., Sroka-Porada, Agnieszka, Ogrodzińska, Wiktoria, Kozakowska, Magdalena, Głowniak-Kwitek, Urszula, Bukowska-Strakova, Karolina, Rzymski, Tomasz, Mazan, Milena, Pakulska, Urszula, Göller, Kristina, Zarzycka, Ewa, and Nogai, Hendrik

Abstract

Introduction:

Published
2023
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24. The Outcome of the First-Line Therapy of Patients with Follicular Lymphoma during COVID-19 Pandemic. a Real-World Data from the Polish Lymphoma Research Group (PLRG)

Author

Paszkiewicz-Kozik, Ewa, Palka, Monika, Debowska, Malgorzata, Szymanski, Marcin, Konska, Agnieszka, Kalicinska, Elzbieta, Tyczynska, Agata, Drozd-Sokolowska, Joanna, Giza, Agnieszka, Swoboda, Ryszard, Dabrowska-Iwanicka, Anna Paulina, Morawska, Marta, Owczarek-Kaczmarek, Justyna, Bolkun, Lukasz, Kopinska, Anna, Wasik-Szczepanek, Ewa, Maksylewicz, Dominika, Wisniewska, Anna, Targonski, Lukasz, Subocz, Edyta, Steckiewicz, Pawel, Domanska-Czyz, Katarzyna, Ostrowska, Beata, Swierkowska, Monika, Krzanowski, Jacek, Druzd-Sitek, Agnieszka, Mroz-Zycinska, Ewa, Romejko-Jarosinska, Joanna, Hus, Iwona, Dlugosz-Danecka, Monika, Lech-Maranda, Ewa, Wrobel, Tomasz, Zaucha, Jan M., and Walewski, Jan

Abstract

Introduction:

Published
2023
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25. Requirement for antiapoptotic MCL-1 during early erythropoiesis

Author

Turnis, Meghan E., Kaminska, Ewa, Smith, Kaitlyn H., Kartchner, Brittany J., Vogel, Peter, Laxton, Jonathan D., Ashmun, Richard A., Ney, Paul A., and Opferman, Joseph T.

Abstract

Although BCL-xL is critical to the survival of mature erythrocytes, it is still unclear whether other antiapoptotic molecules mediate survival during earlier stages of erythropoiesis. Here, we demonstrate that erythroid-specific Mcl1deletion results in embryonic lethality beyond embryonic day 13.5 as a result of severe anemia caused by a lack of mature red blood cells (RBCs). Mcl1-deleted embryos exhibit stunted growth, ischemic necrosis, and decreased RBCs in the blood. Furthermore, we demonstrate that MCL-1 is only required during early definitive erythropoiesis; during later stages, developing erythrocytes become MCL-1 independent and upregulate the expression of BCL-xL. Functionally, MCL-1 relies upon its ability to prevent apoptosis to promote erythroid development because codeletion of the proapoptotic effectors Baxand Bakcan overcome the requirement for MCL-1 expression. Furthermore, ectopic expression of human BCL2 in erythroid progenitors can compensate for Mcl1deletion, indicating redundancy between these 2 antiapoptotic family members. These data clearly demonstrate a requirement for MCL-1 in promoting survival of early erythroid progenitors.

Published
2021
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26. Requirement for antiapoptotic MCL-1 during early erythropoiesis

Author

Turnis, Meghan E., Kaminska, Ewa, Smith, Kaitlyn H., Kartchner, Brittany J., Vogel, Peter, Laxton, Jonathan D., Ashmun, Richard A., Ney, Paul A., and Opferman, Joseph T.

Abstract

Although BCL-xL is critical to the survival of mature erythrocytes, it is still unclear whether other antiapoptotic molecules mediate survival during earlier stages of erythropoiesis. Here, we demonstrate that erythroid-specific Mcl1 deletion results in embryonic lethality beyond embryonic day 13.5 as a result of severe anemia caused by a lack of mature red blood cells (RBCs). Mcl1-deleted embryos exhibit stunted growth, ischemic necrosis, and decreased RBCs in the blood. Furthermore, we demonstrate that MCL-1 is only required during early definitive erythropoiesis; during later stages, developing erythrocytes become MCL-1 independent and upregulate the expression of BCL-xL. Functionally, MCL-1 relies upon its ability to prevent apoptosis to promote erythroid development because codeletion of the proapoptotic effectors Bax and Bak can overcome the requirement for MCL-1 expression. Furthermore, ectopic expression of human BCL2 in erythroid progenitors can compensate for Mcl1 deletion, indicating redundancy between these 2 antiapoptotic family members. These data clearly demonstrate a requirement for MCL-1 in promoting survival of early erythroid progenitors.

Published
2021
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27. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study

Author

Straus, David J., Długosz-Danecka, Monika, Alekseev, Sergey, Illés, Árpád, Picardi, Marco, Lech-Maranda, Ewa, Feldman, Tatyana, Smolewski, Piotr, Savage, Kerry J., Bartlett, Nancy L., Walewski, Jan, Ramchandren, Radhakrishnan, Zinzani, Pier Luigi, Hutchings, Martin, Connors, Joseph M., Radford, John, Munoz, Javier, Kim, Won Seog, Advani, Ranjana, Ansell, Stephen M., Younes, Anas, Miao, Harry, Liu, Rachael, Fenton, Keenan, Forero-Torres, Andres, and Gallamini, Andrea

Abstract

The phase 3 ECHELON-1 study demonstrated that brentuximab vedotin (A) with doxorubicin, vinblastine, and dacarbazine (AVD; A+AVD) exhibited superior modified progression-free survival (PFS) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of patients with stage III/IV classical Hodgkin lymphoma (cHL). Maturing positron emission tomography (PET)-adapted trial data highlight potential limitations of PET-adapted approaches, including toxicities with dose intensification and higher-than-expected relapse rates in PET scan after cycle 2 (PET2)-negative (PET2−) patients. We present an update of the ECHELON-1 study, including an exploratory analysis of 3-year PFS per investigator. A total of 1334 patients with stage III or IV cHL were randomized 1:1 to receive 6 cycles of A+AVD (n = 664) or ABVD (n = 670). Interim PET2 was required. At median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2−patients aged <60 years were 87.2% vs 81.0%, respectively. A beneficial trend in PET2+patients aged <60 years on A+AVD was also observed, with a 3-year PFS rate of 69.2% vs 54.7% with ABVD. The benefit of A+AVD in the intent-to-treat population appeared independent of disease stage and prognostic risk factors. Upon continued follow-up, 78% of patients with peripheral neuropathy on A+AVD had either complete resolution or improvement compared with 83% on ABVD. These data highlight that A+AVD provides a durable efficacy benefit compared with ABVD for frontline stage III/IV cHL, consistent across key subgroups regardless of patient status at PET2, without need for treatment intensification or bleomycin exposure. This trial was registered at www.clinicaltrials.govas #NCT01712490 (EudraCT no. 2011-005450-60).

Published
2020
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28. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study

Author

Straus, David J., Długosz-Danecka, Monika, Alekseev, Sergey, Illés, Árpád, Picardi, Marco, Lech-Maranda, Ewa, Feldman, Tatyana, Smolewski, Piotr, Savage, Kerry J., Bartlett, Nancy L., Walewski, Jan, Ramchandren, Radhakrishnan, Zinzani, Pier Luigi, Hutchings, Martin, Connors, Joseph M., Radford, John, Munoz, Javier, Kim, Won Seog, Advani, Ranjana, Ansell, Stephen M., Younes, Anas, Miao, Harry, Liu, Rachael, Fenton, Keenan, Forero-Torres, Andres, and Gallamini, Andrea

Abstract

The phase 3 ECHELON-1 study demonstrated that brentuximab vedotin (A) with doxorubicin, vinblastine, and dacarbazine (AVD; A+AVD) exhibited superior modified progression-free survival (PFS) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of patients with stage III/IV classical Hodgkin lymphoma (cHL). Maturing positron emission tomography (PET)-adapted trial data highlight potential limitations of PET-adapted approaches, including toxicities with dose intensification and higher-than-expected relapse rates in PET scan after cycle 2 (PET2)-negative (PET2−) patients. We present an update of the ECHELON-1 study, including an exploratory analysis of 3-year PFS per investigator. A total of 1334 patients with stage III or IV cHL were randomized 1:1 to receive 6 cycles of A+AVD (n = 664) or ABVD (n = 670). Interim PET2 was required. At median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2− patients aged <60 years were 87.2% vs 81.0%, respectively. A beneficial trend in PET2+ patients aged <60 years on A+AVD was also observed, with a 3-year PFS rate of 69.2% vs 54.7% with ABVD. The benefit of A+AVD in the intent-to-treat population appeared independent of disease stage and prognostic risk factors. Upon continued follow-up, 78% of patients with peripheral neuropathy on A+AVD had either complete resolution or improvement compared with 83% on ABVD. These data highlight that A+AVD provides a durable efficacy benefit compared with ABVD for frontline stage III/IV cHL, consistent across key subgroups regardless of patient status at PET2, without need for treatment intensification or bleomycin exposure. This trial was registered at www.clinicaltrials.gov as #NCT01712490 (EudraCT no. 2011-005450-60).

Published
2020
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29. A Comparison of Outcomes in Patients with Secondary Acute Promyelocytic Leukemia (APL) and De Novo APL - a Case-Match Retrospective Analysis of Polish Adult Leukemia Group (PALG)

Author

Pluta, Agnieszka, Sobas, Marta Anna, Mikulski, Damian, Krawiec, Kinga, Czemerska, Magdalena, Budziszewska, Bozena Katarzyna, Wróbel, Tomasz, Watek, Marzena, Lech-Marańda, Ewa, Gromek, Tomasz, Hawrylecka, Dorota, Hus, Marek, Zarzycka, Ewa, Zaucha, Jan, Armatys, Anna, Helbig, Grzegorz, Oleksiuk, Jolanta, Piszcz, Jaroslaw, Szczepaniak, Andrzej, Gil, Lidia, Becht, Rafal, Fendler, Wojciech, Giebel, Sebastian, and Wierzbowska, Agnieszka

Published
2022
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31. A Comparison of Outcomes in Patients with Secondary Acute Promyelocytic Leukemia (APL) and De NovoAPL - a Case-Match Retrospective Analysis of Polish Adult Leukemia Group (PALG)

Author

Pluta, Agnieszka, Sobas, Marta Anna, Mikulski, Damian, Krawiec, Kinga, Czemerska, Magdalena, Budziszewska, Bozena Katarzyna, Wróbel, Tomasz, Watek, Marzena, Lech-Marańda, Ewa, Gromek, Tomasz, Hawrylecka, Dorota, Hus, Marek, Zarzycka, Ewa, Zaucha, Jan, Armatys, Anna, Helbig, Grzegorz, Oleksiuk, Jolanta, Piszcz, Jaroslaw, Szczepaniak, Andrzej, Gil, Lidia, Becht, Rafal, Fendler, Wojciech, Giebel, Sebastian, and Wierzbowska, Agnieszka

Published
2022
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33. Safety and Efficacy Results from CLI120-001 a Phase 1 Study in RR-AML and HR-MDS: Update from Higher Dose Levels

Author

Marańda, Ewa Lech, Patkowska, Elżbieta, Jakacka, Natalia, Abboud, Camille N., Burris, Howard A., Solomon, Scott R., Angelosanto, Noemi, Rzymski, Tomasz, Littlewood, Peter, Kuś, Kamil, Sroka-Porada, Agnieszka, Dudziak, Renata, Nogai, Hendrik, Glasmacher, Axel, Bradley, Terrence, Borthakur, Gautam, Mouhayar, Elie, Steckiewicz, Paweł, Kościółek- Zgódka, Sylwia, Szymańska, Agata, and Zaucha, Jan Maciej

Abstract

Background:RVU120, a first-in-class CDK8/19 kinase inhibitor, showed antileukemic activity mediated by inhibition of STAT5 phosphorylation in AML cell lines and patient-derived cells.Clinical activity in a population of patients with relapsed/refractory AML and HR-MDS with poor prognostic factors was shown in a currently ongoing phase 1 dose escalation study (NCT04021368) consistent with the preclinical evidence of both cytotoxic and erythroid and myeloid differentiation effects in cell and mouse models.

Published
2023
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34. Targeting CDK8/CDK19 to Disrupt Leukemic Stem Cell-like Population in Acute Myeloid Leukemia: Exploring RVU120 As a Promising Frontline Therapy

Author

Mazan, Milena, Pakulska, Urszula, Moszyńska, Adrianna, Sroka-Porada, Agnieszka, Szade, Krzysztof Tomasz, Mikula, Michał, Kozakowska, Magdalena, Juszczyński, Przemysław, Wiklik, Katarzyna, Göller, Kristina, Obacz, Marta, Abboud, Camille N., Zaucha, Jan Maciej, Marańda, Ewa Lech, Angelosanto, Noemi, Nogai, Hendrik, and Rzymski, Tomasz

Abstract

Leukemic stem cells (LSCs) are implicated in the initiation, maintenance, and relapse of leukemia. The failure of current standard induction chemotherapy, which primarily targets dividing cells, has been linked to the quiescence of LSCs, leading to resistance to treatment. Consequently, there is an urgent need for novel therapies specifically aimed at eradicating LSCs to achieve more effective and durable treatment responses.

Published
2023
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35. Raman Spectroscopy Imaging in Evaluation of Immune Cells Activation Status

Author

Laskowska, Paulina, Borek-Dorosz, Aleksandra, Nowakowska, Anna Maria, Zolyniak, Aleksandra, Kurtz, Ewa, Szydlowski, Maciej, Juszczyński, Przemysław, Baranska, Malgorzata, Majzner, Katarzyna, and Mrówka, Piotr

Abstract

Introduction: The ability to assess the activation status of immune cells is useful for medical diagnostics and currently also for monitoring the performance of immune cells-based advanced therapy medicinal products (ATMP) such as the chimeric antigen receptor (CAR)-T cells. CAR-T cells numbers and immunophenotype are routinely monitored to avoid poor expansion or exhaustion phenotype. In this study, we utilized Raman spectroscopy (RS) as a label-free, non-destructive method for assessing T cells activation and macrophages polarization (pro-inflammatory M1 vs immunosuppressive M2). RS is a well-defined, non-elastic light scattering-based spectroscopic technique that followed by chemometric analysis provides unique and comprehensive information regarding the molecular structure, metabolic signature and biochemical composition of tissues and cells at subcellular level. To assess if RS would be a valid approach for detection of CAR-T activation we first developed CD19CAR-transduced Jurkat cell line model. Although Jurkat cells, a leukemic T cell line, lack cytolytic activity, they do produce IL-2 and upregulate CD69 upon activation like CAR-T thus serve as a convenient model.

Published
2023
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36. Pirtobrutinib in Post-cBTKi CLL/SLL: ~30 Months Follow-up and Subgroup Analysis With/Without Prior BCL2i from the Phase 1/2 BRUIN Study

Author

Woyach, Jennifer A., Brown, Jennifer R., Ghia, Paolo, Roeker, Lindsey E., Patel, Krish, Eyre, Toby A., Munir, Talha, Lech-Maranda, Ewa, Lamanna, Nicole, Tam, Constantine S., Seymour, John F., Tessoulin, Benoit, Shah, Nirav N., Ujjani, Chaitra S, Fakhri, Bita, Coombs, Catherine C., Flinn, Ian W., Patel, Manish, Nasta, Sunita D., Cohen, Jonathon B., Alencar, Alvaro J., Cheah, Chan Y., Ma, Shuo, Rhodes, Joanna M., Jagadeesh, Deepa, Zinzani, Pier Luigi, Osterborg, Anders, Izutsu, Koji, Tsai, Donald E., Abada, Paolo, Balbas, Minna, Li, Jian, Ruppert, Amy S., Jurczak, Wojciech, and Wierda, William G.

Abstract

Background:The treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has benefited from covalent (c) Bruton tyrosine kinase inhibitors (BTKi), however, therapy can fail due to progression or intolerance. Sequential treatment with B-cell lymphoma 2 protein inhibitor (BCL2i) venetoclax, either as monotherapy or combined with an anti-CD20 monoclonal antibody, has been the primary treatment option for CLL/SLL patients (pts) whose disease has progressed on cBTKi. Pirtobrutinib is a highly selective, non-covalent (reversible) BTKi that demonstrated promising efficacy in patients with relapsed or refractory CLL/SLL (Mato et al, NEJM, 2023). Here, we report on the efficacy of pirtobrutinib treatment in CLL/SLL in the post-cBTKi setting, including subgroups with or without prior BCL2i, using data from the BRUIN study (NCT03740529) with more than 2 years follow-up.

Published
2023
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37. Patient Outcomes after Initial High Dose Versus Low Dose Romiplostim for Inpatient Management of Immune Thrombocytopenia

Author

King, Elizabeth, Abajue, Uzo, Pawlenty, Amanda, Truong, Huong Lan, Fischer, Sabrina, Wolanskyj-Spinner, Alexandra P., Pruthi, Rajiv K., Hook, Carl C., Pardanani, Animesh D., Ashrani, Aneel, Wysokinska, Ewa, Shah, Surbhi, and Go, Ronald S.

Abstract

Introduction: Romiplostim is a thrombopoietin receptor agonist approved by the US FDA for chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The recommended dose is 1 mcg/kg/week subcutaneously, escalated weekly by increments of 1 mcg/kg to achieve and maintain a platelet count of 50 x 10 9/L g ( Kuter et al2021). It has been postulated that starting at the maximum recommended dose of 10 mcg/kg/week in patients with severe bleeding may swiftly increase platelets and minimize bleeding ( Roumier et al2021). However, this approach may also increase the risk of major thrombotic events (TE). It is unclear if the more aggressive dosing strategy results in more rapid, robust responses and a tolerable safety profile compared to the FDA approved approach.

Published
2023
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38. Prognostic Characterization of Advanced Mastocytosis Patients Treated with Midostaurin According to Diagnosis and Mutation-Adjusted Risk Score: A Nation-Wide Ceremast Study of 170 Patients

Author

Heiblig, Mael, Gourguechon, Clement, Guilpain, Philippe, Livideanu, Cristina Bulai, Barete, Stéphane, Agopian, Julie, Brenet, Fabienne, Dubreuil, Patrice, Lemal, Richard, Tournilhac, Olivier, Terriou, Louis, Launay, David, Bouillet, Laurence, Damaj, Gandhi Laurent, Ballul, Thomas, Greco, Céline, Polivka, Laura, Frenzel, Laurent, Meni, Cecile, Bouktit, Hassiba, Gaudy-Marqueste, Caroline, Gousseff, Marie, Le Mouel, Edwige, Neel, Antoine, Ranta, Dana, Jaussaud, Roland, Molina, Thierry Jo, Bruneau, Julie, Lhermitte, Ludovic, Temple, Marie, Kosmider, Olivier, Javier, Rose-Marie, Pelletier, Fabien, Castelain, Florence, Retornaz, Frédérique, Cabrera, Quentin, Zunic, Patricia, Gourin, Marie-Pierre, Wierzbicka-Hainaut, Ewa, Viallard, Jean-Francois, Lavigne, Christian, Hoarau, Cyrille, Durieu, Isabelle, Dimicoli-Salazar, Sophie, Torregrosa-Diaz, Jose-Miguel, Soria, Angele, Arock, Michel, Bodemer, Christine, Lortholary, Olivier, Hermine, Olivier, and Rossignol, Julien

Abstract

Introduction:

Published
2023
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39. A Phase 1 Dose-Escalation Study of the Cladribine Added to CPX-351 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) - the Polish Adult Leukemia Group AML-1/2018 Study

Author

Wierzbowska, Agnieszka, Pluta, Agnieszka, Stelmach, Piotr, Brzozowski, Kamil, Czemerska, Magdalena, Sobas, Marta, Rybka, Justyna, Wróbel, Tomasz, Zarzycka, Ewa, Prejzner, Witold, Zaucha, Jan M., Szczepaniak, Andrzej, Gil, Lidia, and Giebel, Sebastian

Abstract

AW and AP equally contributed to the study

Published
2023
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40. Epigenetic and Transcriptional Consequences of PIM Kinase Activity and Inhibition in Diffuse Large B-Cell Lymphoma (DLBCL)

Author

Debek, Sonia, Komar, Dorota, Garbicz, Filip, Zolyniak, Aleksandra, Pawlak, Michal, Jablonska, Ewa, Szydlowski, Maciej, Skrzypczak, Magdalena, Radomska, Sylwia, Bajor, Małgorzata, Serin, Nazli, Chapuy, Bjoern, and Juszczyński, Przemysław

Abstract

The PIM kinase family consists of 3 proto-oncogenic proteins: PIM1, PIM2 and PIM3, expressed in numerous malignancies, including DLBCL. PIM kinases regulate crucial processes, such as proliferation, apoptosis, metabolism, or migration, therefore their inhibition is of great interest as a potential therapeutic strategy. Although recent studies have shed new light on the biological role of PIMs in lymphoid cancers, the details and mechanisms of PIM's oncogenic effects and the consequences of their inhibition in DLBCL remain insufficiently understood. Earlier studies have demonstrated a potential epigenetic role of PIM through histone H3S10 phosphorylation, however, described only at a single locus. The broad genomic role of PIM in modulating transcription in lymphoma cells remains unclear.

Published
2023
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41. Novel Clinically Useful Inhibitor of Mediator Complex, RVU120, Relives Differentiation Block in MDS/AML

Author

Ajibade, Opeyemi, Pakulska, Urszula, Rabinovich, Emma, Fromowitz, Ariel, Sahu, Srabani, Aminov, Sarah, Ramachandra, Nandini, Aluri, Srinivas, Gordon Mitchell, Shanisha, Carbajal, Milagros, Keska-Izworska, Kinga, Combik, Michał, Obacz, Marta, Adamczyk, Elżbieta, Zaucha, Jan M., Zarzycka, Ewa, Juszczynski, Przemyslaw, Boultwood, Jacqueline, Pellagatti, Andrea, Pradhan, Kith, Steidl, Ulrich, Shastri, Aditi, Zhao, Rongbao, Mazan, Milena, Rzymski, Tomasz, and Verma, Amit

Abstract

Background:

Published
2023
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42. Development of a Same-Day Closed CAR-T Cell Manufacturing Process to Generate Lentivector Loaded Lymphocytes Ready for Subcutaneous Injection

Author

Kerkar, Sid, Liu, Lintao, Betts, Michael, Li, Liang, Andraza, Michelle, Jaruga-Killeen, Ewa, Gowan, Cody, Han, Ting, Shi, Jia, Gao, Rang, Kachgal, Suraj, Wade, Gregory, Zhang, Wei, and Frost, Gregory

Abstract

Background:Adoptive T-cell therapies with CD19 chimeric antigen receptors (CAR) are now the standard of care for refractory/recurrent hematologic B-cell malignancies. However, challenges remain in delivering a more fit cell product that can be manufactured in a more timely and cost-effective manner. To address these challenges, a rapid same-day fully closed manufacturing process was developed to generate a more fit product for subcutaneous administration and to enable an efficient transition from early-phase clinical trials to commercial-scale production.

Published
2023
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43. Pirtobrutinib in Richter Transformation: Updated Efficacy and Safety Results with 18-Month Median Survival Follow-up from the Phase 1/2 BRUIN Study

Author

Wierda, William G., Shah, Nirav N., Cheah, Chan Yoon, Lewis, David, Hoffmann, Marc S., Coombs, Catherine C., Lamanna, Nicole, Ma, Shuo, Jagadeesh, Deepa, Munir, Talha, Wang, Yucai, Eyre, Toby A., Rhodes, Joanna M., McKinney, Matthew, Lech-Maranda, Ewa, Tam, Constantine S., Jurczak, Wojciech, Izutsu, Koji, Alencar, Alvaro J., Patel, Manish, Seymour, John F., Woyach, Jennifer A., Roeker, Lindsey E., Thompson, Philip A., Abada, Paolo, Ho, Caleb, Marella, Narasimha, Wang, Chunxiao, Ruppert, Amy S., Chandrasekharan Nair, Binoj, Liu, Hui, Tsai, Donald E., and Ghia, Paolo

Abstract

Background:Richter transformation (RT) occurs in up to 10% of patients with chronic lymphocytic leukemia (CLL), typically presents as an aggressive diffuse large B-cell lymphoma (DLBCL) and is associated with poor survival. RT has no approved standard therapy; and clinical trial enrollment is the preferred first line of therapy. Pirtobrutinib, a highly selective, non-covalent (reversible) BTKi, that inhibits both wildtype and C481-mutant BTK with equal low nM potency, has favorable oral pharmacology that enables continuous BTK inhibition throughout the dosing interval. Pirtobrutinib demonstrated durable overall response rates (ORR) and was well tolerated in patients (pts) with poor-prognosis B-cell malignancies regardless of prior therapy. Here we provide updated safety and efficacy of pirtobrutinib in RT pts from the phase 1/2 BRUIN trial (NCT03740529).

Published
2023
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44. Zilovertamab Vedotin (MK-2140) in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results from the Phase 2 Waveline-004 Study

Author

Ozcan, Muhit, Lv, Fangfang, Norasetthada, Lalita, Paszkiewicz-Kozik, Ewa, Díaz Schmidt, Joaquin, Modi, Dipenkumar, Fosså, Alexander, Goyal, Sagun, Kim, Won Seog, Lee, Seung Tae, Santoro, Armando, Sonmez, Mehmet, Pathiraja, Kumudu, Reddy, Nishitha, Marinello, Patricia, and Song, Yuqin

Abstract

Background:DLBCL is an aggressive non-Hodgkin lymphoma (NHL) that is often curable with frontline therapy, but up to 50% of patients (pts) will develop relapsed or refractory (R/R) disease. Treatment options are limited for pts with R/R DLBCL who have progressed after or are ineligible for autologous stem cell transplant (ASCT) or chimeric antigen receptor (CAR) T-cell therapy. ROR1 is an oncofetal transmembrane protein that is expressed in DLBCL. Zilovertamab vedotin, an antibody-drug conjugate comprising a humanized monoclonal antibody against ROR1, a proteolytically cleavable linker, and the antimicrotubule agent monomethyl auristatin E (MMAE), initially demonstrated promising antitumor activity and manageable safety in R/R NHL in the phase 1 waveLINE-001 study. Early results from the single-arm, open-label, phase 2 waveLINE-004 study (NCT05144841) showed that zilovertamab vedotin had clinically meaningful antitumor activity and manageable safety in pts with R/R DLBCL who progressed after or were ineligible for ASCT and/or CAR T-cell therapy. We present updated results from waveLINE-004.

Published
2023
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45. Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed / Refractory Marginal Zone Lymphoma: Results from Phase 1/2 BRUIN Study

Author

Patel, Krish, Vose, Julie M., Nasta, Sunita D., Brown, Jennifer R., Maddocks, Kami J., Woyach, Jennifer A., Shah, Nirav N., Fakhri, Bita, Tessoulin, Benoit, Ma, Shuo, Jagadeesh, Deepa, Lech-Maranda, Ewa, Coombs, Catherine C., Patel, Manish, Rhodes, Joanna M., Ujjani, Chaitra S, Hoffmann, Marc S., Cheah, Chan Y, Munir, Talha, Lewis, David, Scarfo, Lydia, Eyre, Toby A., Alencar, Alvaro J., Cohen, Jonathon B., Zelenetz, Andrew D., Tsai, Donald E., Li, Mei, Bian, Faith, Abada, Paolo, and Zinzani, Pier Luigi

Abstract

Background:Marginal zone lymphoma (MZL) is an indolent lymphoma that is typically treated with chemoimmunotherapy, but often requires sequential therapy. Covalent (c) Bruton tyrosine kinase inhibitors (BTKi) are increasingly being used in the relapsed or refractory (R/R) setting, but options for pts with MZL after cBTKi therapy may be limited. Pirtobrutinib, a highly selective, non-covalent (reversible) BTKi has favorable once daily oral pharmacology that enables continuous BTK inhibition throughout the dosing interval, regardless of intrinsic rate of BTK turnover. Pirtobrutinib has demonstrated promising efficacy and tolerability in pts with poor-prognosis B-cell malignancies following prior therapy, including prior cBTKi. Pirtobrutinib is approved in the USA to treat R/R mantle cell lymphoma after at least two lines of systemic therapy including prior BTKi treatment. Here we report the safety and efficacy of pirtobrutinib in pts with MZL from the BRUIN study (NCT03740529).

Published
2023
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46. H2-K1on MLL-AF9Leukemia Cells Facilitates the Escape of NK Cell-Mediated Immune Surveillance

Author

Ghosh, Somadri, Rodriguez Zabala, Maria, Dushime, Gladys Telliam, Reinbach, Katrin, Ramakrishnan, Ramprasad, Sitnicka, Ewa, and Järås, Marcus

Abstract

Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults, and prognosis is poor; 5-year survival approximately 30%. Recently, there is an emerging recognition of the innate immune system, in particular Natural killer (NK) cells and macrophages, for immune surveillance against AML, but the mechanistic basis for this is mostly unknow. Identifying how AML cells escape immune surveillance by NK cells may translate into new treatment opportunities for AML patients.

Published
2023
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47. The Need to Consider Pro-Active Treatment for Cerebral Artery Conditional Blood Velocity Determined By Transcranial Doppler Ultrasonography (TCD) in Sickle Cell Disease (SCD)

Author

Okpala, Iheanyi, Modebe, Emmanuel, Nonyelu, Charles, Duru, Augustine, Ezenwosu, Osita, Chukwu, Barth, Madu, Anazoeze Jude, Ezekekwu, Chinedu Anthony, Aneke, John Chinawaeze, Izuka, Mildred, Nri-Ezedi, Chisom, Nnachi, Oluomachi Charity, Eze, Alozie Uchenna, Ajuba, Ifeoma, Okwummuo, Emeka Paul, Chilaka, Jane, Onodugo, Chinenye, Fidelis-Ewa, Uwaoma, Agwu, Obineche, Muoghalu, Ebele, Anigbogu, Ikechukwu, Okoye, Helen Chioma, Efobi, Chilota Chibuife, Ejiofor, Obiora, Ugwu, Ngozi, Maduka, Collins, Iloanusi, Nneka, Ugwu, Angela, Okocha, Emmanuel Chide, and Ulasi, Thomas

Abstract

Introduction Cerebral artery peak systolic blood velocity (PSV) or timed average mean of the maximum blood velocity (TAMMV) determined by TCD in children of age 2-16 years with SCD is normal (NV) if TAMMV <170 cm/sec or PSV <200 cm/sec; abnormal (AV) if TAMMV > 200cm/s or PSV > 250 cm/sec; and conditional (CV) if TAMMV is 170-199cm/sec or PSV 200-249 cm/sec. Internal carotid (ICA) or middle cerebral (MCA) artery AV is associated with a stroke risk of 10% /year, CV a risk of 3-4% /year [Adams et al. Long-Term stroke risk in children with SCD screened with TCD. Ann Neurol 1997; 42: 699-704]. Blood transfusion or hydroxycarbamide is used to treat AV, but active treatment is currently not considered the standard of care for conditional velocity, although it could progress to abnormal values.

Published
2023
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49. Stratification Using ECOG, ADL and HCT-CI Scales, but Not CGA Enables Identifying Elderly AML Patients Fit for Intensive Chemotherapy - a Multicenter Study from Polish Adult Leukemia Group

Author

Budziszewska, Bozena Katarzyna, Łomiak, Michał, Barankiewicz, Joanna, Patkowska, Elzbieta, Helbig, Grzegorz, Bolkun, Lukasz, Irga-Staniukiewicz, Anna, Kiżewska, Anna, Piekarska, Agnieszka, Koclęga, Anna, Pluta, Agnieszka, Kuydowicz, Marta, Kościółek- Zgódka, Sylwia, Cichocka, Edyta, Malenda, Agata, Wójcik, Karol, Gromek, Tomasz, Małecki, Piotr, Grosicki, Sebastian, Wierzbowska, Agnieszka, and Lech-Maranda, Ewa

Abstract

Introduction:A key part of decision-making in older AML patients is an insightful clinical assessment before qualification for treatment with intensive chemotherapy (IC). It was demonstrated that among the patients initially deemed “fit” for IC, there are vulnerable patients who experience greater treatment toxicity and have poorer outcomes. Comprehensive geriatric assessment (CGA) is a well-recognized tool for identifying such patients. However, due to its time-consuming nature, it is not commonly used. A number of other prognostic models exist, but none of them enable fast and optimal identification of patients eligible for IC.

Published
2023
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50. Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed/Refractory Follicular Lymphoma: Results from the Phase 1/2 BRUIN Study

Author

Shah, Nirav N., Zinzani, Pier Luigi, Wang, Michael L., Nasta, Sunita D., Lech-Maranda, Ewa, Ogawa, Yoshiaki, Fakhri, Bita, Kuss, Bryone, Miyashita, Kaname, Patel, Krish, Coombs, Catherine C., Ma, Shuo, Patel, Manish, Barve, Minal A., Tessoulin, Benoit, Stathis, Anastasios, Kim, Won Seog, Ennishi, Daisuke, Hashimoto, Daigo, Kojima, Kensuke, Zelenetz, Andrew D., Cohen, Jonathon B., Vose, Julie M., Maddocks, Kami J., Munir, Talha, Sun, Fangfang, Bian, Faith, Tsai, Donald E., Abada, Paolo, and Cheah, Chan Y.

Abstract

Background:Follicular lymphoma (FL) is a chronic and incurable disease requiring multiple lines of therapy for patients (pts) with relapsed/refractory (R/R) disease. Covalent Bruton tyrosine kinase inhibitors (cBTKi) have transformed the management of select B-cell malignancies, in particular chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). However, despite the transformative impact in CLL and MCL, the efficacy of single-agent cBTKi has been limited in pts with R/R FL, with an overall response rate (ORR) of 20.9% to 37.5% (Gopal et al, J Clin Oncol, 2018; Bartlett et al, Blood, 2018). Pirtobrutinib, a highly selective, non-covalent (reversible) BTKi, inhibits both wildtype and C481-mutant BTK with equal low nM potency and has a favorable oral pharmacology that enables continuous BTK inhibition throughout the once-daily dosing interval. Pirtobrutinib has demonstrated promising efficacy and tolerability in pts with poor-prognosis B-cell malignancies following prior therapy, including cBTKi. Here, we report the safety and efficacy of pirtobrutinib in a cohort of pts with R/R FL from the BRUIN study (NCT03740529).

Published
2023
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