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2. Outcomes in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy.

Author

Martinelli, Giovanni, Neubauer, Andreas, Sierra, Jorge, Montesinos, Pau, Recher, Christian, Yoon, Sung-Soo, Maeda, Yoshinobu, Hosono, Naoko, Onozawa, Masahiro, Kato, Takayasu, Kim, Hee-Je, Hasabou, Nahla, Nuthethi, Rishita, Tiu, Ramon, Levis, Mark, Perl, Alexander, Larson, Richard, Podoltsev, Nikolai, Strickland, Stephen, Wang, Eunice, Atallah, Ehab, and Schiller, Gary

Subjects
Acute myelogenous leukemia, FLT3 inhibitor, FLT3 mutation, Hematopoietic stem cell transplantation, Post-transplantation maintenance therapy, Adult, Humans, fms-Like Tyrosine Kinase 3, Leukemia, Myeloid, Acute, Aniline Compounds, Recurrence
Abstract

The fms-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib improved the survival of patients with relapsed or refractory (R/R) FLT3-mutated acute myelogenous leukemia (AML) in the phase 3 ADMIRAL trial. In this study, we assessed survival and relapse rates of patients in the ADMIRAL trial who underwent hematopoietic stem cell transplantation (HSCT), as well as safety outcomes in patients who received post-transplantation gilteritinib maintenance therapy. ADMIRAL was a global phase 3 randomized controlled trial that enrolled adult patients with FLT3-mutated R/R AML. Patients with R/R AML who harbored FLT3 internal tandem duplication mutations in the juxtamembrane domain or D835/I836 point mutations in the tyrosine kinase domain were randomized (2:1) to gilteritinib (120 mg/day) or to preselected high- or low-intensity salvage chemotherapy (1 or 2 cycles). Patients in the gilteritinib arm who proceeded to HSCT could receive post-transplantation gilteritinib maintenance therapy if they were within 30 to 90 days post-transplantation and had achieved composite complete remission (CRc) with successful engraftment and no post-transplantation complications. Adverse events (AEs) during HSCT were recorded in the gilteritinib arm only. Survival outcomes and the cumulative incidence of relapse were assessed in patients who underwent HSCT during the trial. Treatment-emergent AEs were evaluated in patients who restarted gilteritinib as post-transplantation maintenance therapy. Patients in the gilteritinib arm underwent HSCT more frequently than those in the chemotherapy arm (26% [n = 64] versus 15% [n = 19]). For all transplantation recipients, 12- and 24-month overall survival (OS) rates were 68% and 47%, respectively. Despite a trend toward longer OS after pretransplantation CRc, post-transplantation survival was comparable in the 2 arms. Patients who resumed gilteritinib after HSCT had a low relapse rate after pretransplantation CRc (20%) or CR (0%). The most common AEs observed with post-transplantation gilteritinib therapy were increased alanine aminotransferase level (45%), pyrexia (43%), and diarrhea (40%); grade ≥3 AEs were related primarily to myelosuppression. The incidences of grade ≥III acute graft-versus-host disease and related mortality were low. Post-transplantation survival was similar across the 2 study arms in the ADMIRAL trial, but higher remission rates with gilteritinib facilitated receipt of HSCT. Gilteritinib as post-transplantation maintenance therapy had a stable safety and tolerability profile and was associated with low relapse rates. Taken together, these data support a preference for bridging therapy with gilteritinib over chemotherapy in transplantation-eligible patients.

Published
2023

3. Immuno markers in newly diagnosed glioblastoma patients underwent Stupp protocol after neurosurgery: a retrospective series

Author

Gurrieri, Lorena, Mercatali, Laura, Ibrahim, Toni, Fausti, Valentina, Dall’Agata, Monia, Riva, Nada, Ranallo, Nicoletta, Pasini, Giuseppe, Tazzari, Marcella, Foca, Flavia, Bartolini, Daniela, Riccioni, Luca, Cavatorta, Chiara, Morigi, Federico Paolo, Bulgarelli, Jenny, Cocchi, Claudia, Ghini, Virginia, Tosatto, Luigino, Martinelli, Giovanni, Pession, Andrea, and Ridolfi, Laura

Published
2023
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4. MEK1/2 regulate normal BCR and ABL1 tumor-suppressor functions to dictate ATO response in TKI-resistant Ph+ leukemia

Author

Mazzera, Laura, Abeltino, Manuela, Lombardi, Guerino, Cantoni, Anna Maria, Jottini, Stefano, Corradi, Attilio, Ricca, Micaela, Rossetti, Elena, Armando, Federico, Peli, Angelo, Ferrari, Anna, Martinelli, Giovanni, Scupoli, Maria Teresa, Visco, Carlo, Bonifacio, Massimiliano, Ripamonti, Alessia, Gambacorti-Passerini, Carlo, Bonati, Antonio, Perris, Roberto, and Lunghi, Paolo

Published
2023
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6. Venetoclax and Cobimetinib in Relapsed/Refractory AML: A Phase 1b Trial

Author

Konopleva, Marina Y., Dail, Monique, Daver, Naval G., Garcia, Jacqueline S., Jonas, Brian A., Yee, Karen W.L., Kelly, Kevin R., Vey, Norbert, Assouline, Sarit, Roboz, Gail J., Paolini, Stefania, Pollyea, Daniel A., Tafuri, Agostino, Brandwein, Joseph M., Pigneux, Arnaud, Powell, Bayard L., Fenaux, Pierre, Olin, Rebecca L., Visani, Giuseppe, Martinelli, Giovanni, Onishi, Maika, Wang, Jue, Huang, Weize, Dunshee, Diana R., Hamidi, Habib, Ott, Marion G., Hong, Wan-Jen, and Andreeff, Michael

Published
2024
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7. Exploring the ATR-CHK1 pathway in the response of doxorubicin-induced DNA damages in acute lymphoblastic leukemia cells

Author

Ghelli Luserna Di Rorà, Andrea, Ghetti, Martina, Ledda, Lorenzo, Ferrari, Anna, Bocconcelli, Matteo, Padella, Antonella, Napolitano, Roberta, Fontana, Maria Chiara, Liverani, Chiara, Imbrogno, Enrica, Bochicchio, Maria Teresa, Paganelli, Matteo, Robustelli, Valentina, Sanogo, Seydou, Cerchione, Claudio, Fumagalli, Monica, Rondoni, Michela, Imovilli, Annalisa, Musuraca, Gerardo, Martinelli, Giovanni, and Simonetti, Giorgia

Published
2023
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9. 10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial

Author

Finke, Jürgen, Schaap, Nicolaas Petrus Michael, Zucenka, Andrius, Metzelder, Stephan, Jost, Edgar, Perić, Zinaida, Forghieri, Fabio, Allione, Bernadino, Martelli, Maurizio, Iori, Anna Paola, Wittnebel, Sebastian, Mengarelli, Andrea, Imovilli, Annalisa, Olivieri, Attilio, De Prijck, Bernard José Marie, van der Poel, Marjolein W.M., Junghanß, Christian, Salih, Helmut Rainer, Tafuri, Agostino, Guimarães, José Eduardo, Musso, Maurizio, De Fabritiis, Paolo, Chevallier, Patrice, Selleslag, Dominik Luc, Cascavilla, Nicola, Berneman, Zwi, Jaspers, Aurélie, Zuffa, Eliana, Vanstraelen, Gaëtan, Visani, Giuseppe, Cuijpers, Maria Louisa Henriëtte, De Becker, Ann, Mianulli, Anna Maria, Hackanson, Björn, Mihaylov, Georgi Georgiev, Martinelli, Giovanni, Paolini, Stefania, Zinzani, Pier Luigi, Henkes, Martin, Al-Ali, Haifa Kathrin, La Rosée, Paul, Chierichini, Anna, Cudillo, Laura, Specchia, Giorgina, Šimec, Njetočka Gredelj, Capalbo, Silvana Franca, Spinosa, Giuseppina, Molica, Stefano, de Jonge-Peeters, Susan Dorothé, Lübbert, Michael, Wijermans, Pierre W, Kicinski, Michal, Chantepie, Sylvain, Van der Velden, Walter J F M, Noppeney, Richard, Griškevičius, Laimonas, Neubauer, Andreas, Crysandt, Martina, Vrhovac, Radovan, Luppi, Mario, Fuhrmann, Stephan, Audisio, Ernesta, Candoni, Anna, Legrand, Olivier, Foà, Robin, Gaidano, Gianluca, van Lammeren-Venema, Danielle, Posthuma, Eduardus F M, Hoogendoorn, Mels, Giraut, Anne, Stevens-Kroef, Marian, Jansen, Joop H, de Graaf, Aniek O, Efficace, Fabio, Ammatuna, Emanuele, Vilque, Jean-Pierre, Wäsch, Ralph, Becker, Heiko, Blijlevens, Nicole, Dührsen, Ulrich, Baron, Frédéric, Suciu, Stefan, Amadori, Sergio, Venditti, Adriano, and Huls, Gerwin

Published
2023
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10. Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study

Author

Pabst, Thomas, Papayannidis, Cristina, Demirkan, Fatih, Doronin, Vadim, Fogliatto, Laura M, Guttke, Christina, Gyan, Emmanuel, Hamad, Nada, Herrera, Pilar, Hultberg, Anna, Jacobs, Julie, Johnson, Amy J, Langlois, Angélique, Ma, Xuewen, Martinelli, Giovanni, Arnan, Montserrat, Müller, Rouven, Nottage, Kerri, Ofran, Yishai, Özcan, Muhit, Samoilova, Olga, Tolbert, Jaszianne A, Trudel, Géralyn C, Xiu, Liang, Vey, Norbert, and Wei, Andrew H

Published
2023
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14. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome–positive relapsed/refractory acute lymphoblastic leukemia

Author

Stock, Wendy, Martinelli, Giovanni, Stelljes, Matthias, DeAngelo, Daniel J, Gökbuget, Nicola, Advani, Anjali S, O’Brien, Susan, Liedtke, Michaela, Merchant, Akil A, Cassaday, Ryan D, Wang, Tao, Zhang, Hui, Vandendries, Erik, Jabbour, Elias, Marks, David I, and Kantarjian, Hagop M

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Pediatric Cancer, Cancer, Rare Diseases, Hematology, Pediatric, Transplantation, Childhood Leukemia, Regenerative Medicine, Pediatric Research Initiative, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Good Health and Well Being, Hematopoietic Stem Cell Transplantation, Humans, Inotuzumab Ozogamicin, Neoplasm, Residual, Philadelphia Chromosome, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, acute lymphoblastic leukemia, efficacy, hematopoietic stem cell transplantation, inotuzumab ozogamicin, Philadelphia chromosome, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundPatients with relapsed/refractory (R/R) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) have a poor prognosis and limited treatment options.MethodsThe efficacy of inotuzumab ozogamicin (InO), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, was evaluated in R/R ALL patients in the phase 1/2 study 1010 (NCT01363297) and open-label, randomized, phase 3 study 1022 (INO-VATE; NCT01564784). This analysis focused specifically on Ph+ R/R ALL patients. In study 1022, Ph+ patients were randomly assigned 1:1 to InO (n = 22) or standard intensive chemotherapy (SC) (n = 27) and 16 Ph+ patients in study 1010 received InO.ResultsIn study 1022, rates of complete remission/complete remission with incomplete hematologic recovery (CR/CRi) and minimal residual disease (MRD) negativity (patients achieving CR/CRi) were higher with InO (CR/CRi = 73%; MRD = 81%) versus SC (CR/CRi = 56%; MRD = 33%). The corresponding rates in study 1010 were 56% (CR/CRi) and 100% (MRD). The hematopoietic stem cell transplantation (HSCT) rate in study 1022 was 41% versus 19% for InO versus SC; however, there was no benefit in overall survival (median OS: 8.7 vs 8.4 months; hazard ratio, 1.17 [95% CI, 0.64-2.14]). The probability of being event-free (progression-free survival) at 12 months was greater with InO versus SC (20.1% vs 4.8%).ConclusionGiven the substantial improvement in responses and rates of HSCT, InO is an important treatment option for patients with R/R Ph+ ALL. Future studies need to consider better characterization of disease characteristics, more sensitive MRD measurements, MRD-directed therapy before HSCT, and potentially combination therapies, including tyrosine kinase inhibitors.

Published
2021

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

Author

Perl, Alexander E, Altman, Jessica K, Hosono, Naoko, Montesinos, Pau, Podoltsev, Nikolai, Martinelli, Giovanni, Smith, Catherine C, Levis, Mark J, Roellig, Christoph, Gross-Langenhoff, Marco, Hasabou, Nahla, Lu, Qiaoyang, and Tiu, Ramon V

Subjects
AML, acute myeloid leukemia, FLT3 mutation, tyrosine kinase inhibitor, Clinical Sciences, Oncology and Carcinogenesis, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

The fms-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib is indicated for relapsed or refractory (R/R) FLT3-mutated acute myeloid leukemia (AML), based on its observed superior response and survival outcomes compared with salvage chemotherapy (SC). Frontline use of FLT3 tyrosine kinase inhibitors (TKIs) midostaurin and sorafenib may contribute to cross-resistance to single-agent gilteritinib in the R/R AML setting but has not been well characterized. To clarify the potential clinical impact of prior TKI use, we retrospectively compared clinical outcomes in patients with R/R FLT3-mutated AML in the CHRYSALIS and ADMIRAL trials who received prior midostaurin or sorafenib against those without prior FLT3 TKI exposure. Similarly high rates of composite complete remission (CRc) were observed in patients who received a FLT3 TKI before gilteritinib (CHRYSALIS, 42%; ADMIRAL, 52%) and those without prior FLT3 TKI therapy (CHRYSALIS, 43%; ADMIRAL, 55%). Among patients who received a prior FLT3 TKI in ADMIRAL, a higher CRc rate (52%) and trend toward longer median overall survival was observed in the gilteritinib arm versus the SC arm (CRc = 20%; overall survival, 5.1 months; HR = 0.602; 95% CI: 0.299, 1.210). Remission duration was shorter with prior FLT3 TKI exposure. These findings support gilteritinib for FLT3-mutated R/R AML after prior sorafenib or midostaurin.

Published
2021

17. Pegaspargase-modified risk-oriented program for adult acute lymphoblastic leukemia: results of the GIMEMA LAL1913 trial

Author

Bassan, Renato, Chiaretti, Sabina, Della Starza, Irene, Spinelli, Orietta, Santoro, Alessandra, Paoloni, Francesca, Messina, Monica, Elia, Loredana, De Propris, Maria Stefania, Scattolin, Anna Maria, Audisio, Ernesta, Marbello, Laura, Borlenghi, Erika, Zappasodi, Patrizia, Mauro, Elisa, Martinelli, Giovanni, Mattei, Daniele, Fracchiolla, Nicola, Bocchia, Monica, De Fabritiis, Paolo, Bonifacio, Massimiliano, Candoni, Anna, Cassibba, Vincenzo, Di Bartolomeo, Paolo, Latte, Giancarlo, Trappolini, Silvia, Guarini, Anna, Vitale, Antonella, Fazi, Paola, Piciocchi, Alfonso, Rambaldi, Alessandro, and Foà, Robin

Published
2023
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22. Venetoclax and idasanutlin in relapsed/refractory AML: a nonrandomized, open-label phase 1b trial

Author

Daver, Naval G., Dail, Monique, Garcia, Jacqueline S., Jonas, Brian A., Yee, Karen W. L., Kelly, Kevin R., Vey, Norbert, Assouline, Sarit, Roboz, Gail J., Paolini, Stefania, Pollyea, Daniel A., Tafuri, Agostino, Brandwein, Joseph M., Pigneux, Arnaud, Powell, Bayard L., Fenaux, Pierre, Olin, Rebecca L., Visani, Giuseppe, Martinelli, Giovanni, Onishi, Maika, Wang, Jue, Huang, Weize, Green, Cherie, Ott, Marion G., Hong, Wan-Jen, Konopleva, Marina Y., and Andreeff, Michael

Published
2023
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23. Exploring the role of the combination of FDG PET plus whole body MRI for staging newly diagnosed and relapsed/refractory multiple myeloma: A prospective trial.

Author

Cerchione, Claudio, primary, Nappi, Davide, additional, Marchesini, Matteo, additional, Cangini, Delia, additional, Ronconi, Sonia, additional, Ceccolini, Michela, additional, Prochowski Iamurri, Andrea, additional, Matteucci, Federica, additional, Simonetti, Giorgia, additional, Musuraca, Gerardo, additional, Martinelli, Giovanni, additional, and Rossi, Alice, additional

Published
2024
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24. 68Ga-PSMA PET/CT response and clinical outcomes in patients treated with enzalutamide as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC): Results of a prospective study.

Author

Giunta, Emilio Francesco, primary, Caroli, Paola, additional, Scarpi, Emanuela, additional, Altavilla, Amelia, additional, Marini, Irene, additional, Celli, Monica, additional, Casadei, Chiara, additional, Lolli, Cristian, additional, Schepisi, Giuseppe, additional, Bleve, Sara, additional, Brighi, Nicole, additional, Cursano, Maria Concetta, additional, Martinelli, Giovanni, additional, Matteucci, Federica, additional, and De Giorgi, Ugo, additional

Published
2024
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25. A phase 1b/2 study of pivekimab sunirine (PVEK, IMGN632) in combination with venetoclax/azacitidine for patients with newly diagnosed CD123-positive acute myeloid leukemia.

Author

Daver, Naval Guastad, primary, Montesinos, Pau, additional, Altman, Jessica K., additional, Advani, Anjali S., additional, Wang, Eunice S., additional, Garciaz, Sylvain, additional, Martinelli, Giovanni, additional, Roboz, Gail J., additional, Walter, Roland B., additional, Begna, Kebede, additional, Lunghi, Monia, additional, Platzbecker, Uwe, additional, Vyas, Paresh, additional, Burke, Patrick William, additional, Curti, Antonio, additional, DeAngelo, Daniel J., additional, Gastaud, Lauris, additional, Schliemann, Christoph, additional, Oshrine, Benjamin, additional, and Sallman, David Andrew, additional

Published
2024
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31. 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.

Published
2022
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32. Follow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial

Author

Perl, Alexander E., Larson, Richard A., Podoltsev, Nikolai A., Strickland, Stephen, Wang, Eunice S., Atallah, Ehab, Schiller, Gary J., Martinelli, Giovanni, Neubauer, Andreas, Sierra, Jorge, Montesinos, Pau, Récher, Christian, Yoon, Sung-Soo, Hosono, Naoko, Onozawa, Masahiro, Chiba, Shigeru, Kim, Hee-Je, Hasabou, Nahla, Lu, Qiaoyang, Tiu, Ramon, and Levis, Mark J.

Published
2022
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33. ELN2017 risk stratification improves outcome prediction when applied to the prospective GIMEMA AML1310 protocol

Author

Buccisano, Francesco, Palmieri, Raffaele, Piciocchi, Alfonso, Arena, Valentina, Candoni, Anna, Melillo, Lorella, Calafiore, Valeria, Cairoli, Roberto, de Fabritiis, Paolo, Storti, Gabriella, Salutari, Prassede, Lanza, Francesco, Martinelli, Giovanni, Luppi, Mario, Capria, Saveria, Maurillo, Luca, Del Principe, Maria Ilaria, Paterno, Giovangiacinto, Irno Consalvo, Maria Antonietta, Ottone, Tiziana, Lavorgna, Serena, Voso, Maria Teresa, Fazi, Paola, Vignetti, Marco, Arcese, William, and Venditti, Adriano

Published
2022
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37. Author Correction: Genome-wide association study identifies susceptibility loci for acute myeloid leukemia

Author

Lin, Wei-Yu, Fordham, Sarah E., Hungate, Eric, Sunter, Nicola J., Elstob, Claire, Xu, Yaobo, Park, Catherine, Quante, Anne, Strauch, Konstantin, Gieger, Christian, Skol, Andrew, Rahman, Thahira, Sucheston-Campbell, Lara, Wang, Junke, Hahn, Theresa, Clay-Gilmour, Alyssa I., Jones, Gail L., Marr, Helen J., Jackson, Graham H., Menne, Tobias, Collin, Mathew, Ivey, Adam, Hills, Robert K., Burnett, Alan K., Russell, Nigel H., Fitzgibbon, Jude, Larson, Richard A., Le Beau, Michelle M., Stock, Wendy, Heidenreich, Olaf, Alharbi, Abrar, Allsup, David J., Houlston, Richard S., Norden, Jean, Dickinson, Anne M., Douglas, Elisabeth, Lendrem, Clare, Daly, Ann K., Palm, Louise, Piechocki, Kim, Jeffries, Sally, Bornhäuser, Martin, Röllig, Christoph, Altmann, Heidi, Ruhnke, Leo, Kunadt, Desiree, Wagenführ, Lisa, Cordell, Heather J., Darlay, Rebecca, Andersen, Mette K., Fontana, Maria C., Martinelli, Giovanni, Marconi, Giovanni, Sanz, Miguel A., Cervera, José, Gómez-Seguí, Inés, Cluzeau, Thomas, Moreilhon, Chimène, Raynaud, Sophie, Sill, Heinz, Voso, Maria Teresa, Lo-Coco, Francesco, Dombret, Hervé, Cheok, Meyling, Preudhomme, Claude, Gale, Rosemary E., Linch, David, Gaal-Wesinger, Julia, Masszi, Andras, Nowak, Daniel, Hofmann, Wolf-Karsten, Gilkes, Amanda, Porkka, Kimmo, Milosevic Feenstra, Jelena D., Kralovics, Robert, Grimwade, David, Meggendorfer, Manja, Haferlach, Torsten, Krizsán, Szilvia, Bödör, Csaba, Stölzel, Friedrich, Onel, Kenan, and Allan, James M.

Published
2022
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38. INCB84344-201: Ponatinib and steroids in frontline therapy for unfit patients with Ph+ acute lymphoblastic leukemia

Author

Martinelli, Giovanni, Papayannidis, Cristina, Piciocchi, Alfonso, Robustelli, Valentina, Soverini, Simona, Terragna, Carolina, Marconi, Giovanni, Lemoli, Roberto M., Guolo, Fabio, Fornaro, Antonella, Lunghi, Monia, de Fabritiis, Paolo, Candoni, Anna, Selleri, Carmine, Simonetti, Federico, Bocchia, Monica, Vitale, Antonella, Frison, Luca, Tedeschi, Alessandra, Cuneo, Antonio, Bonifacio, Massimiliano, Martelli, Maria Paola, D'Ardia, Stefano, Trappolini, Silvia, Tosi, Patrizia, Galieni, Piero, Fabbiano, Francesco, Abbenante, Maria Chiara, Granier, Muriel, Zhu, Zhaoyin, Wang, Mingyue, Sartor, Chiara, Paolini, Stefania, Cavo, Michele, Foà, Robin, Fazi, Paola, Vignetti, Marco, and Baccarani, Michele

Published
2022
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41. Integrated genomic-metabolic classification of acute myeloid leukemia defines a subgroup with NPM1 and cohesin/DNA damage mutations

Author

Simonetti, Giorgia, Mengucci, Carlo, Padella, Antonella, Fonzi, Eugenio, Picone, Gianfranco, Delpino, Claudio, Nanni, Jacopo, De Tommaso, Rossella, Franchini, Eugenia, Papayannidis, Cristina, Marconi, Giovanni, Pazzaglia, Martina, Perricone, Margherita, Scarpi, Emanuela, Fontana, Maria Chiara, Bruno, Samantha, Tebaldi, Michela, Ferrari, Anna, Bochicchio, Maria Teresa, Ghelli Luserna Di Rorà, Andrea, Ghetti, Martina, Napolitano, Roberta, Astolfi, Annalisa, Baldazzi, Carmen, Guadagnuolo, Viviana, Ottaviani, Emanuela, Iacobucci, Ilaria, Cavo, Michele, Castellani, Gastone, Haferlach, Torsten, Remondini, Daniel, Capozzi, Francesco, and Martinelli, Giovanni

Published
2021
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42. Phase 2b study of 2 dosing regimens of quizartinib monotherapy in FLT3-ITD-mutated, relapsed or refractory AML.

Author

Cortes, Jorge E, Tallman, Martin S, Schiller, Gary J, Trone, Denise, Gammon, Guy, Goldberg, Stuart L, Perl, Alexander E, Marie, Jean-Pierre, Martinelli, Giovanni, Kantarjian, Hagop M, and Levis, Mark J

Subjects
Clinical Research, Rare Diseases, Hematology, Childhood Leukemia, Pediatric Research Initiative, Clinical Trials and Supportive Activities, Cancer, Pediatric, Pediatric Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Agents, Benzothiazoles, Dose-Response Relationship, Drug, Female, Gastrointestinal Diseases, Gene Duplication, Heart Diseases, Hematologic Diseases, Humans, Kaplan-Meier Estimate, Leukemia, Myeloid, Acute, Male, Middle Aged, Oncogene Proteins, Fusion, Phenylurea Compounds, Protein Kinase Inhibitors, Salvage Therapy, Tandem Repeat Sequences, Young Adult, fms-Like Tyrosine Kinase 3, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Paediatrics and Reproductive Medicine, Immunology
Abstract

This randomized, open-label, phase 2b study (NCT01565668) evaluated the efficacy and safety of 2 dosing regimens of quizartinib monotherapy in patients with relapsed/refractory (R/R) FLT3-internal tandem duplication (ITD)-mutated acute myeloid leukemia (AML) who previously underwent transplant or 1 second-line salvage therapy. Patients (N = 76) were randomly assigned to 30- or 60-mg/day doses (escalations to 60 or 90 mg/day, respectively, permitted for lack/loss of response) of single-agent oral quizartinib dihydrochloride. Allelic frequency of at least 10% was defined as FLT3-ITD-mutated disease. Coprimary endpoints were composite complete remission (CRc) rates and incidence of QT interval corrected by Fridericia's formula (QTcF) of more than 480 ms (grade 2 or greater). Secondary endpoints included overall survival (OS), duration of CRc, bridge to transplant, and safety. CRc rates were 47% in both groups, similar to earlier reports with higher quizartinib doses. Incidence of QTcF above 480 ms was 11% and 17%, and QTcF above 500 ms was 5% and 3% in the 30- and 60-mg groups, respectively, which is less than earlier reports with higher doses of quizartinib. Median OS (20.9 and 27.3 weeks), duration of CRc (4.2 and 9.1 weeks), and bridge to transplant rates (32% and 42%) were higher in the 60-mg groups than in the 30-mg group. Dose escalation occurred in 61% and 14% of patients in the 30- and 60-mg groups, respectively. This high clinical activity of quizartinib at the evaluated doses is consistent with previous reports with an improved safety profile. Need to dose-escalate more than half of patients who received quizartinib 30 mg also supports further investigation of treatment with quizartinib 60 mg/day.

Published
2018

43. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial

Author

Cortes, Jorge, Perl, Alexander E, Döhner, Hartmut, Kantarjian, Hagop, Martinelli, Giovanni, Kovacsovics, Tibor, Rousselot, Philippe, Steffen, Björn, Dombret, Hervé, Estey, Elihu, Strickland, Stephen, Altman, Jessica K, Baldus, Claudia D, Burnett, Alan, Krämer, Alwin, Russell, Nigel, Shah, Neil P, Smith, Catherine C, Wang, Eunice S, Ifrah, Norbert, Gammon, Guy, Trone, Denise, Lazzaretto, Deborah, and Levis, Mark

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Hematology, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Administration, Oral, Adult, Aged, Benzothiazoles, Canada, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Europe, Female, Humans, Internationality, Leukemia, Myeloid, Acute, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Recurrence, Local, Phenylurea Compounds, Prognosis, Survival Rate, Treatment Outcome, United States, Young Adult, fms-Like Tyrosine Kinase 3, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundOld age and FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations in patients with acute myeloid leukaemia are associated with early relapse and poor survival. Quizartinib is an oral, highly potent, and selective next-generation FLT3 inhibitor with clinical antileukaemic activity in relapsed or refractory acute myeloid leukaemia. We aimed to assess the efficacy and safety of single-agent quizartinib in patients with relapsed or refractory acute myeloid leukaemia.MethodsWe did an open-label, multicentre, single-arm, phase 2 trial at 76 hospitals and cancer centres in the USA, Europe, and Canada. We enrolled patients with morphologically documented primary acute myeloid leukaemia or acute myeloid leukaemia secondary to myelodysplastic syndromes and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 into two predefined, independent cohorts: patients who were aged 60 years or older with relapsed or refractory acute myeloid leukaemia within 1 year after first-line therapy (cohort 1), and those who were 18 years or older with relapsed or refractory disease following salvage chemotherapy or haemopoietic stem cell transplantation (cohort 2). Patients with an FLT3-ITD allelic frequency of more than 10% were considered as FLT3-ITD positive, whereas all other patients were considered as FLT3-ITD negative. Patients received quizartinib once daily as an oral solution; the initial 17 patients received 200 mg per day but the QTcF interval was prolonged for more than 60 ms above baseline in some of these patients. Subsequently, doses were amended for all patients to 135 mg per day for men and 90 mg per day for women. The co-primary endpoints were the proportion of patients who achieved a composite complete remission (defined as complete remission + complete remission with incomplete platelet recovery + complete remission with incomplete haematological recovery) and the proportion of patients who achieved a complete remission. Efficacy and safety analyses included all patients who received at least one dose of quizartinib (ie, the intention-to-treat population). Patients with a locally assessed post-treatment bone marrow aspirate or biopsy were included in efficacy analyses by response; all other patients were considered to have an unknown response. This study is registered with ClinicalTrials.gov, number NCT00989261, and with the European Clinical Trials Database, EudraCT 2009-013093-41, and is completed.FindingsBetween Nov 19, 2009, and Oct 31, 2011, a total of 333 patients were enrolled (157 in cohort 1 and 176 in cohort 2). In cohort 1, 63 (56%) of 112 FLT3-ITD-positive patients and 16 (36%) of 44 FLT3-ITD-negative patients achieved composite complete remission, with three (3%) FLT3-ITD-positive patients and two (5%) FLT3-ITD-negative patients achieving complete remission. In cohort 2, 62 (46%) of 136 FLT3-ITD-positive patients achieved composite complete remission with five (4%) achieving complete remission, whereas 12 (30%) of 40 FLT3-ITD-negative patients achieved composite complete remission with one (3%) achieving complete remission. Across both cohorts (ie, the intention-to-treat population of 333 patients), grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients were febrile neutropenia (76 [23%] of 333), anaemia (75 [23%]), thrombocytopenia (39 [12%]), QT interval corrected using Fridericia's formula (QTcF) prolongation (33 [10%]), neutropenia (31 [9%]), leucopenia (22 [7%]), decreased platelet count (20 [6%]), and pneumonia (17 [5%]). Serious adverse events occurring in 5% or more of patients were febrile neutropenia (126 [38%] of 333; 76 treatment related), acute myeloid leukaemia progression (73 [22%]), pneumonia (40 [12%]; 14 treatment related), QTcF prolongation (33 [10%]; 32 treatment related), sepsis (25 [8%]; eight treatment related), and pyrexia (18 [5%]; nine treatment related). Notable serious adverse events occurring in less than 5% of patients were torsades de pointes (one [

Published
2018

44. Unlocking the potential of synthetic patients for accelerating clinical trials: Results of the first GIMEMA experience on acute myeloid leukemia patients

Author

Piciocchi, Alfonso, primary, Cipriani, Marta, additional, Messina, Monica, additional, Marconi, Giovanni, additional, Arena, Valentina, additional, Soddu, Stefano, additional, Crea, Enrico, additional, Feraco, Maria Valeria, additional, Ferrante, Marco, additional, La Sala, Edoardo, additional, Fazi, Paola, additional, Buccisano, Francesco, additional, Voso, Maria Teresa, additional, Martinelli, Giovanni, additional, Venditti, Adriano, additional, and Vignetti, Marco, additional

Published
2024
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45. Management of ALL in Adults: 2023 ELN Recommendations from a European Expert Panel

Author

Gökbuget, Nicola, primary, Boissel, Nicolas, additional, Chiaretti, Sabina, additional, Dombret, Herve, additional, Doubek, Michael, additional, Fielding, Adele K, additional, Foà, Robin, additional, Giebel, Sebastian, additional, Hoelzer, Dieter, additional, Hunault, Mathilde, additional, Marks, David I, additional, Martinelli, Giovanni, additional, Ottmann, Oliver, additional, Rijneveld, Anita W., additional, Rousselot, Philippe, additional, Ribera, Josep-Maria, additional, and Bassan, Renato, additional

Published
2024
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46. Diagnosis, Prognostic Factors and Assessment of ALL in Adults: 2023 ELN Recommendations from a European Expert Panel

Author

Gökbuget, Nicola, primary, Boissel, Nicolas, additional, Chiaretti, Sabina, additional, Dombret, Herve, additional, Doubek, Michael, additional, Fielding, Adele K, additional, Foà, Robin, additional, Giebel, Sebastian, additional, Hoelzer, Dieter, additional, Hunault, Mathilde, additional, Marks, David I, additional, Martinelli, Giovanni, additional, Ottmann, Oliver G, additional, Rijneveld, Anita W., additional, Rousselot, Philippe, additional, Ribera, Josep-Maria, additional, and Bassan, Renato, additional

Published
2024
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48. BCR-ABL1 compound mutants: prevalence, spectrum and correlation with tyrosine kinase inhibitor resistance in a consecutive series of Philadelphia chromosome-positive leukemia patients analyzed by NGS

Author

Soverini, Simona, Martelli, Margherita, Bavaro, Luana, De Benedittis, Caterina, Sica, Simona, Sorà, Federica, Iurlo, Alessandra, Bonifacio, Massimiliano, Pregno, Patrizia, Galimberti, Sara, Lunghi, Francesca, Albano, Francesco, D’Adda, Mariella, Crugnola, Monica, Capodanno, Isabella, Castagnetti, Fausto, Gugliotta, Gabriele, Papayannidis, Cristina, Rosti, Gianantonio, Percesepe, Antonio, Mignone, Flavio, Baccarani, Michele, Martinelli, Giovanni, and Cavo, Michele

Published
2021
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49. Clinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib

Author

Perl, Alexander E., Hosono, Naoko, Montesinos, Pau, Podoltsev, Nikolai, Martinelli, Giovanni, Panoskaltsis, Nicki, Recher, Christian, Smith, Catherine C., Levis, Mark J., Strickland, Stephen, Röllig, Christoph, Groß-Langenhoff, Marco, Chou, Wen-Chien, Lee, Je-Hwan, Yokoyama, Hisayuki, Hasabou, Nahla, Lu, Qiaoyang, Tiu, Ramon V., and Altman, Jessica K.

Published
2022
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50. Clinical Outcomes in Patients with FLT3-ITD-Mutated Relapsed/Refractory Acute Myelogenous Leukemia Undergoing Hematopoietic Stem Cell Transplantation after Quizartinib or Salvage Chemotherapy in the QuANTUM-R Trial

Author

Ganguly, Siddhartha, Cortes, Jorge E., Krämer, Alwin, Levis, Mark J., Martinelli, Giovanni, Perl, Alexander E., Russell, Nigel H., Arunachalam, Meena, Santos, Cedric Dos, Gammon, Guy, Lesegretain, Arnaud, Mires, Derek E., Pham, Hoang, Wang, Yibin, and Khaled, Samer K.

Published
2021
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