Citations 65
P719: RANDOMIZED PHASE 1-2 STUDY TO ASSESS SAFETY AND EFFICACY OF LOW-DOSE (LD) ORAL DECITABINE/CEDAZURIDINE (ASTX727) IN LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS) PATIENTS: INTERIM SAFETY ANALYSIS
Garcia‐Manero, Guillermo , Bachishvili, Kimo, Saini, Lalit , Amin, Harshad, Lübbert, Michael , Maness-Harris, Lori, Foran, James M. , Selleslag, Dominik, Cirici, Blanca Xicoy, Sallman, David A. , Al‐Kali, Aref , Zhu, Nancy , Santillana, Guillermo Sanz, Yimer, Habte, Cripe, Larry D., Priego, Victor, Odenike, Olatoyosi , Heyrman, Bert , Vachhani, Pankit , Sano, Yuri, Mirakhur, Beloo, Oganesian, Aram , Yacoub, Abdulraheem , Griffiths, Elizabeth A. , Zeidan, Amer M. , Traer, Elie , Mohan, Sanjay , Pollyea, Daniel Aaron , Berdeja, Jesús G. , Al‐Ali, Haifa Kathrin , Font, Patricia , Santini, Valeria , Valcárcel, David , Keer, Harold N
HemaSphere | August 25, 2023 | Volume: 7 | Issue: S3 | Pages: e551265b
P489: PROGNOSTIC IMPACT OF “MULTI-HIT” VERSUS “SINGLE-HIT” TP53 MUTATION IN PATIENTS WITH ACUTE MYELOID LEUKEMIA: RESULTS FROM THE CONSORTIUM ON MYELOID MALIGNANCIES AND NEOPLASTIC DISEASES (COMMAND)
Shallis, Rory M. , Nanaa, Ahmad , Bradshaw, Danielle , Stahl, Maximillian , Palmisiano, Neil , Litzow, Mark R. , Badar, Talha , Atallah, Ehab , Goldberg, Aaron D. , Saliba, Antoine N. , Patel, Anand , Bewersdorf, Jan Philipp , DuVall, Adam , Burkart, Madelyn , Abaza, Yasmin , Murthy, Guru Subramanian Guru , Kota, Vamsi , Zeidan, Amer M.
HemaSphere | August 8, 2023 | Volume: 7 | Issue: S3 | Pages: e429374f
P735: EFFICACY AND SAFETY OF ORAL DECITABINE/CEDAZURIDINE (ASTX727) IN THE CMML SUBPOPULATION FROM PHASE 2 AND ASCERTAIN PHASE 3 STUDIES
McCloskey, James, Yee, Karen , Al‐Kali, Aref , Deeg, H. Joachim , Patel, Prapti A. , Keating, Mary‐Margaret, Zhu, Nancy , Gabrail, Nashat , Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi , Kantarjian, Hagop, Busque, Lambert , Buckstein, Rena , Amin, Harshad, Randhawa, Jasleen K., Dao, Kim‐Hien, Chan, Winny, Oganesian, Aram , Sano, Yuri, Mirakhur, Beloo, Garcia‐Manero, Guillermo , Savona, Michael R. , Griffiths, Elizabeth A. , Zeidan, Amer M. , Sabloff, Mitchell , Dezern, Amy Elizabeth , O'Connell, Casey Lee , Roboz, Gail J. , Leber, Brian F. , Keer, Harold N
HemaSphere | August 8, 2023 | Volume: 7 | Issue: S3 | Pages: e1342620
S170: MYELODYSPLASTIC NEOPLASMS (MDS) CLASSIFICATION FROM WHO 2017 TO WHO 2022 AND ICC 2022): AN EXPANDED ANALYSIS OF 7017 PATIENTS ON BEHALF OF THE INTERNATIONAL CONSORTIUM FOR MDS (ICMDS)
Ball, Somdeb, Travaglino, Erica , Ali, Najla Al , Fenaux, Pierre , Haferlach, Torsten , Schwabkey, Zaker , Brunner, Andrew M. , Bennett, John M. , Buckstein, Rena , Hasserjian, Robert P. , Odenike, Olatoyosi , Patnaik, Mrinal M. , Stahl, Maximillian , Xu, Mina L. , Sweet, Kendra , Padron, Eric , Sallman, David A. , Komrokji, Rami S. , Maggioni, Giulia , Platzbecker, Uwe , Santini, Valeria , Díez‐Campelo, María , Singh, Avani , Jain, Akriti Gupta , Aguirre, Luis E. E. , Tinsley, Sara , Chan, Onyee , Xie, Zhuoer , Kuykendall, Andrew , Bejar, Rafael , Bewersdorf, Jan Philipp , Carraway, Hetty E. , Dezern, Amy Elizabeth , Griffiths, Elizabeth A. , Halene, Stephanie , Loghavi, Sanam , Roboz, Gail J. , Sekeres, Mikkael A. , Steensma, David P. , Savona, Michael R. , Taylor, Justin , Lancet, Jeffrey E. , List, Alan F. , Zeidan, Amer M. , Della Porta, Matteo Giovanni
HemaSphere | August 8, 2023 | Volume: 7 | Issue: S3 | Pages: e616260d
Prolonged Survival in Bi-Allelic TP53-Mutated (TP53mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)
McCloskey, James, Yee, Karen , Al‐Kali, Aref , Deeg, Joachim, Patel, Prapti A. , Keating, Mary‐Margaret, Dao, Kim‐Hien, Zhu, Nancy , Gabrail, Nashat , Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi , Kantarjian, Hagop, Busque, Lambert , Buckstein, Rena , Amin, Harshad, Randhawa, Jasleen K., Oganesian, Aram , Chan, Winny, Azab, Mohammad , Garcia‐Manero, Guillermo , Savona, Michael R. , Griffiths, Elizabeth A. , Zeidan, Amer M. , Sabloff, Mitchell , Dezern, Amy Elizabeth , O'Connell, Casey Lee , Roboz, Gail J. , Leber, Brian F. , Hao, Yong
Blood | November 29, 2022 | Volume: 140 | Issue: Supplement 1 | Pages: 2066-2069
Umbrella Trial in Myeloid Malignancies: The Myelomatch National Clinical Trials Network Precision Medicine Initiative
Little, Richard F. , Ansher, Sherry S., Gore, Steven D. , Harris, Lyndsay N. , Langan, Erin , Luger, Selina M. , Michaelis, Laura C. , Odenike, Olatoyosi , Radich, Jerald P. , Ramineni, Bhanu, Stiff, Patrick J. , Stone, Richard M. , Worthington, Katherine H, Zhang, Jianqiao , Litzow, Mark R. , Othus, Megan , Assouline, Sarit E. , Atallah, Ehab , Lindsley, R Coleman , Freidlin, Boris , Hourigan, Christopher S. , Ivy, S. Percy , Jiwani, Shahanawaz S. , Patton, David R. , Perales, Miguel‐Angel , Ramineni, Bhanumati , Salk, Jesse J. , Stock, Wendy , Uy, Geoffrey L. , Williams, P. Mickey, Wood, Brent L. , Yee, Laura M , Zeidan, Amer M. , Erba, Harry Paul
Blood | November 28, 2022 | Volume: 140 | Issue: Supplement 1 | Pages: 9057-9060
The Characteristics and Prognosis of Patients with Clonal Cytopenias of Undetermined Significance, Including Cancer and Therapy-Related Clonal Cytopenias
Smith, Alexandra N., Ali, Najla Al , Coombs, Catherine C. , Foran, James M. , Tsai, Charlton , Amanam, Idoroenyi , Lai, Catherine , Deeg, Joachim, Dinner, Shira, Chandhok, Namrata S. , Soong, Deborah, Brunner, Andrew M. , Geyer, Susan M. , Padron, Eric , Patnaik, Mrinal M. , Al‐Kali, Aref , Xie, Zhuoer , Komrokji, Rami S. , Patel, Anand , Saygin, Caner , Zeidan, Amer M. , Bewersdorf, Jan Philipp , Kishtagari, Ashwin , Zeidner, Joshua F. , Madanat, Yazan F. , Badar, Talha , Desai, Pinkal , Griffiths, Elizabeth A. , Malki, Monzr M. Al , Lai, Catherine, Adès, Lionel , Yi, Cecilia Arana , Osman, Afaf E.G. , Abaza, Yasmin , Taylor, Justin , Carraway, Hetty E. , Singh, Abhay , Savona, Michael R.
Blood | November 28, 2022 | Volume: 140 | Issue: Supplement 1 | Pages: 2887-2890
An agenda to advance research in myelodysplastic syndromes: a TOP 10 priority list from the first international workshop in MDS
Stahl, Maximilian , Wei, Andrew H. , Savona, Michael R. , Xu, Mina L. , Xie, Zhuoer , Sanz, Guillermo , Sallman, David A. , Patnaik, Mrinal M. , Padron, Eric , Odenike, Olatoyosi , Nazha, Aziz , Nimer, Stephen D. , Majeti, Ravindra , Little, Richard F. , Gore, Steven D. , Kutchroo, Vijay, Kim, Tae Kon , Kim, Nina , Hasserjian, Robert P. , Greenberg, Peter L. , Fenaux, Pierre , Churpek, Jane E. , Brunner, Andrew M. , Borate, Uma , Bennett, John M. , Platzbecker, Uwe , Buckstein, Rena , Zeidan, Amer M. , Wei, Andrew H , Savona, Michael R , Xie, Zhuoer , Taylor, Justin , Sanz, Guillermo F , Santini, Valeria , Roboz, Gail J , Patnaik, Mrinal , Little, Richard F , Komrokji, Rami S , Kim, Tae Kon , Kim, Nina , Hourigan, Christopher S , Halene, Stephanie , Griffiths, Elizabeth A. , Greenberg, Peter L , Daver, Naval , Carraway, Hetty E. , Bejar, Rafael , Boultwood, Jacqueline , Loghavi, Sanam , Platzbecker, Uwe , Steensma, David P , Majeti, Ravindra , Zeidan, Amer M , Churpek, Jane E , Abdel‐Wahab, Omar , Starczynowski, Daniel T. , Santini, Valeria , Roboz, Gail J. , List, Alan F. , Komrokji, Rami S. , Hourigan, Christopher S. , Figueroa, María E. , Efficace, Fabio , Dezern, Amy Elizabeth , Della Porta, Matteo Giovanni , Daver, Naval , Boultwood, Jacqueline , Loghavi, Sanam , Bewersdorf, Jan Philipp , Steensma, David P. , Sekeres, Mikkael A. , Churpek, Jane
Blood Advances | October 19, 2022 | Volume: 7 | Issue: 12 | Pages: 2709-2714
P787: SABATOLIMAB (MBG453) COMBINATION TREATMENT REGIMENS FOR PATIENTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES: THE MYELODYSPLASTIC SYNDROMES STUDIES IN THE STIMULUS IMMUNO-MYELOID CLINICAL TRIAL PROGRAM
Al‐Kali, Aref , Borate, Uma , Cluzeau, Thomas , DeZern, A. E., Kobata, Kazuma, Lyons, Roger M. , Sallman, David A. , Xiao, Zhijian , Hoef, Marlies Van, Nourry-Boulot, Claire, Sadek, Islam Mohamad, IORDAN, Ana-Maria, Sabo, Jennifer L., Garcia‐Manero, G., Zeidan, Amer M. , Esteve, Jordi , Giagounidis, Aristoteles , Platzbecker, Uwe , Santini, Valeria , Sanz, Guillermo , Sekeres, Mikkael A. , Wei, Andrew H. , Ma, Fei
HemaSphere | June 23, 2022 | Volume: 6 | Issue: No issue available | Pages: 682-683
Gilteritinib clinical activity in relapsed/refractory FLT3 mutated acute myeloid leukemia previously treated with FLT3 inhibitors
Rahman, Zaid Abdel , Grenet, Justin , Boisclair, Stéphanie , Bewersdorf, Jan Philipp , Barth, Dylan , Fraga, Martina , Bixby, Dale L. , Zeidan, Amer M. , Desai, Pankil , Mannis, Gabriel N. , Deutsch, Yehuda E., Dinner, Shira, Frankfurt, Olga, Litzow, Mark R. , Al‐Kali, Aref , Foran, James M. , Sproat, Lisa Z., Jovanovic, Borko, Perl, Alexander E. , Altman, Jessica K. , Rahman, Zaid H. Abdel , Numan, Yazan , Abdel Rahman, Zaid, Bewersdorf, Jan P , Yilmaz, Musa , Litzow, Mark R. , Daver, Naval , Altman, Jessica K , Abdel Rahman, Zaid H , Zeidan, Amer M , Collins, Cailin T. , Yılmaz, Musa , Abaza, Yasmin , Daver, Naval
American Journal of Hematology | January 4, 2022 | Volume: 97 | Issue: 3 | Pages: 322-328
AbstractGilteritinib is approved for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) with an FLT3‐mutation (FLT3mut+). However, the gilteritinib phase 3 ADMIRAL study (Perl et al NEJM 2019) was conducted prior to widespread adoption of either midostaurin as a component of standard intensive induction and consolidation or posttransplant FLT3 inhibitor maintenance. We performed a retrospective analysis using data from 11 US centers and where we identified 113 patients who received gilteritinib alone or as combination therapy for the treatment of R/R FLT3mut+ AML. The composite complete remission (CR) rate (CRc, defined as CR + CRi + CR with incomplete platelet recovery [CRp]) was 48.7% (n = 55). The CRc rate after treatment with gilteritinib in patients who were treated with only prior 7+3 and midostaurin with or without consolidation was 58% with a median survival of 7.8 months. Survival was longest in patients who obtained a CR, particularly a cMRD (clinical minimal or measurable residual disease) negative response; this remained significant after censoring at the time of stem cell transplant. The mitogen‐activated protein kinase pathway activating mutations that are known for gilteritinib resistance (NRAS, KRAS, and PTPN11) had lower CRc (35% vs. 60.5%) and lower median overall survival than patients' whose leukemia did not express these mutations (4.9 months vs. 7.8 months) (HR 2.4; 95% CI 1. 5.4) p value <.01.