Oral Decitabine/Cedazuridine Vs Intravenous Decitabine for Acute Myeloid Leukemia: Final Results of a Randomized, Crossover, Registration-Enabling, Pharmacokinetics Study

被引:0
|
作者
Geissler, Klaus [1 ,2 ]
Koristek, Zdenek [3 ]
Del Castillo, Teresa Bernal [4 ]
Novak, Jan [5 ,6 ]
Macias, Gabriela Rodriguez [7 ]
Metzelder, Stephan [8 ]
Illes, Arpad [9 ]
Nagy, Agnes [10 ]
Mayer, Jiri [11 ,12 ]
Arnan Sangerman, Montserrat [13 ]
Keating, Mary-Margaret [14 ]
Krauter, Juergen [15 ]
Lunghi, Monia [16 ]
Fracchiolla, Nicola [17 ]
Platzbecker, Uwe [18 ]
Santini, Valeria [19 ]
Chan, Danna [20 ]
Mirakhur, Beloo [20 ]
Sano, Yuri [20 ]
Oganesian, Aram [20 ]
Keer, Harold N. [20 ]
Luebbert, Michael [21 ]
机构
[1] Clin Hietzing, Vienna, Austria
[2] Sigmund Freud Univ, Vienna, Austria
[3] Univ Hosp Ostrava, Ostrava, Czech Republic
[4] Hosp Univ Cent Asturias, ISPA, IUOPA, Oviedo, Spain
[5] Charles Univ Prague, Prague, Czech Republic
[6] Fac Hosp Kralovske Vinohrady, Prague, Czech Republic
[7] Hosp Univ Gregorio Maranon, Madrid, Spain
[8] Philipps Univ Marburg, Marburg, Germany
[9] Univ Debrecen, Dept Hematol, Fac Med, Debrecen, Hungary
[10] Univ Pecs, Pecs, Hungary
[11] Masaryk Univ, Brno, Czech Republic
[12] Univ Hosp Brno, Brno, Czech Republic
[13] Univ Barcelona, Dept Hematol, Inst Catala Oncol, Hosp Duran & Reynals,Inst Invest Biomed Bellvitge, Barcelona, Spain
[14] Queen Elizabeth II QEII Hlth Sci Ctr, Halifax, NS, Canada
[15] Stadt Klinikum Braunschweig, Dept Hematol & Oncol, Braunschweig, Germany
[16] Univ Piemonte Orientale, Dept Translat Med, Div Hematol, Novara, Italy
[17] Fdn IRCCS Ca Granda Osped Maggiore Policlin Milan, Hematol Unit, Milan, Italy
[18] Univ Hosp Leipzig, Dept Hematol, Leipzig, Germany
[19] Univ Florence, DMSC, AOU Careggi, MDS Unit, Florence, Italy
[20] Astex Pharmaceut Inc, Pleasanton, CA USA
[21] Univ Med Ctr Freiburg, Freiburg, Germany
关键词
D O I
10.1182/blood-2023-173092
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页数:5
相关论文
共 50 条
  • [21] Final Report of a Randomized Study of Decitabine Versus Conventional Care (CC) for Maintenance Therapy in Patients with Intermediate and High Risk Acute Myeloid Leukemia (AML) in First or Subsequent Complete Remission (CR)
    Boumber, Yanis
    Issa, Jean-Pierre
    Jorgensen, Jeffrey L.
    Faderl, Stefan
    Castoro, Ryan J.
    Autry, Jane
    Garcia-Manero, Guillermo
    Borthakur, Gautam
    Jabbour, Elias
    Estrov, Zeev
    Cortes, Jorge E.
    Kantarjian, Hagop M.
    Ravandi, Farhad
    BLOOD, 2011, 118 (21) : 664 - 665
  • [22] Phase 2 Study of ASTX727 (cedazuridine/decitabine) Plus Venetoclax in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Previously Untreated, Elderly Patients with AML Unfit for Chemotherapy
    Abuasab, Tareq
    Garcia-Manero, Guillermo
    Short, Nicholas
    Alvarado, Yesid
    Issa, Ghayas C.
    Islam, Rubiul
    Maiti, Abhishek
    Yilmaz, Musa
    Jain, Nitin
    Masarova, Lucia
    Kornblau, Steven M.
    Jabbour, Elias
    Pemmaraju, Naveen
    Montalban-Bravo, Guillermo
    Pierce, Sherry A.
    DiNardo, Courtney D.
    Kadia, Tapan M.
    Daver, Naval
    Konopleva, Marina
    Kantarjian, Hagop
    Ravandi, Farhad
    BLOOD, 2022, 140 : 3324 - 3326
  • [23] Valproate and Retinoic Acid in Combination With Decitabine in Elderly Nonfit Patients With Acute Myeloid Leukemia: Results of a Multicenter, Randomized, 2 x 2, Phase II Trial
    Luebbert, Michael
    Grishina, Olga
    Schmoor, Claudia
    Schlenk, Richard F.
    Jost, Edgar
    Crysandt, Martina
    Heuser, Michael
    Thol, Felicitas
    Salih, Helmut R.
    Schittenhelm, Marcus M.
    Germing, Ulrich
    Kuendgen, Andrea
    Goetze, Katharina S.
    Lindemann, Hans-Walter
    Mueller-Tidow, Carsten
    Heil, Gerhard
    Scholl, Sebastian
    Bug, Gesine
    Schwaenen, Carsten
    Giagounidis, Aristoteles
    Neubauer, Andreas
    Krauter, Juergen
    Brugger, Wolfram
    De Wit, Maike
    Waesch, Ralph
    Becker, Heiko
    May, Annette M.
    Duyster, Justus
    Doehner, Konstanze
    Ganser, Arnold
    Hackanson, Bjoern
    Doehner, Hartmut
    JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (03) : 257 - +
  • [24] Decitabine/Cedazuridine (ASTX727) Combined with a Molecularly-Targeted Agent (Venetoclax, Gilteritinib, Ivosidenib, or Enasidenib) As Personalized Maintenance Therapy in Acute Myeloid Leukemia: First Results from a Phase 1b Study
    Bazinet, Alexandre
    Kantarjian, Hagop M.
    Ravandi, Farhad
    Short, Nicholas J.
    Daver, Naval
    Ohanian, Maro
    Yilmaz, Musa
    Chien, Kelly S.
    Maiti, Abhishek
    DiNardo, Courtney D.
    Ishizawa, Jo
    Masarova, Lucia
    Bull-Linderman, Debra
    Borthakur, Gautam
    Jabbour, Elias
    Garcia-Manero, Guillermo
    Kadia, Tapan M.
    BLOOD, 2023, 142
  • [25] Phase Ib/II Study (NCT02488408 / BGBC003) of Bemcentinib Monotherapy or in Combination with Cytarabine or Decitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS): FINAL Results
    Loges, Sonja
    Heuser, Michael
    Chromik, Jolanta
    Sutamtewagul, Grerk
    Kapp-Schwoerer, Silke
    Crugnola, Monica
    Di Renzo, Nicola
    Lemoli, Roberto Massimo
    Mattei, Daniele Giovanni
    Ben Batalla, Isabel
    Waizenegger, Jonas
    Janning, Melanie
    Rieckmann, Lisa-Marie
    Imbusch, Charles
    Beumer, Niklas
    Micklam, David
    Gorcea-Carson, Claudia
    Oliva, Cristina
    Fiedler, Walter
    Alvarado-Valero, Yesid
    McCracken, Nigel
    Gjertsen, Bjorn T.
    BLOOD, 2023, 142
  • [26] Randomized study of decitabine versus observation or continued cytotoxic chemotherapy in patients with intermediate and poor risk acute myeloid leukemia in first or subsequent complete remission
    Ravandi, Farhad
    Issa, Jean-Pierre
    Faderl, Stefan
    Garcia-Manero, Guillermo
    Hood, Mary
    Jorgensen, Jeffrey
    Lee, Ming
    O'Brien, Susan
    Estey, Elihu
    Borthakur, Gautam
    Ferrajoli, Alessandra
    Verstovsek, Srdan
    Corbes, Jorge
    Kantarjian, Hagop
    BLOOD, 2007, 110 (11) : 841A - 841A
  • [27] Results of Phase 2 Randomized Study of Low-Dose Decitabine With or Without Valproic Acid in Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia
    Issa, Jean-Pierre
    Garcia-Manero, Guillermo
    Huang, Xuelin
    Cortes, Jorge
    Ravandi, Farhad
    Jabbour, Elias
    Borthakur, Gautam
    Brandt, Mark
    Pierce, Sherry
    Kantarjian, Hagop M.
    CANCER, 2015, 121 (04) : 556 - 561
  • [28] Long-Term Subgroup Analyses from Azacitidine Vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the Pethema Registry
    Labrador, Jorge
    la Fuente, Adolfode
    Martinez-Cuadron, David
    Rodriguez-Veiga, Rebeca
    Serrano, Josefina
    Tormo, Mar
    Perez-Simon, Jose
    Ramos, Fernando
    del Castillo, Teresa Bernal
    Lopez-Pavia, Maria
    Trigo, Fernanda
    Sanchez, Pilar Martinez
    Rodriguez-Gutierrez, Juan Ignacio
    Rodriguez, Carlos
    Gil, Cristina
    Garcia, Daniel
    Vives, Susana
    Foncillas, Maria Angeles
    Encinas, Manuel Perez
    Novo, Andres
    Recio, Isabel
    Macias, Gabriela Rodriguez
    Burgues, Juan Miguel Bergua
    Concepcion, Victor Noriega
    Lavilla, Esperanza
    Perez, Alicia Roldan
    Sanz, Miguel A.
    Montesinos, Pau
    BLOOD, 2021, 138
  • [29] Phase 2 study of ASTX727 (cedazuridine/decitabine) plus venetoclax (ven) in patients with relapsed/refractory acute myeloid leukemia (AML) or previously untreated, elderly patients (pts) unfit for chemotherapy.
    Ravandi, Farhad
    Abuasab, Tareq
    Valero, Yesid Alvarado
    Issa, Ghayas C.
    Islam, Rabiul
    Short, Nicholas James
    Yilmaz, Musa
    Jain, Nitin
    Masarova, Lucia
    Kornblau, Steven Mitchell
    Jabbour, Elias
    Pemmaraju, Naveen
    Bravo, Guillermo Montalban
    Pierce, Sherry
    Dinardo, Courtney Denton
    Kadia, Tapan M.
    Daver, Naval Guastad
    Konopleva, Marina
    Garcia-Manero, Guillermo
    JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (16)
  • [30] Preliminary Results of a Phase II Study of Low Dose Decitabine as a Single Agent in Older Patients (age≥60) with Previously Untreated Acute Myeloid Leukemia (AML)
    Blum, William
    Klisovic, Rebecca
    Liu, Shujun
    Garzon, Ramiro
    Kefauver, Cheryl
    Liu, Zhongfa
    Mickle, Jon
    Devine, Hollie
    Devine, Steve
    Grever, Michael R.
    Chan, Kenneth K.
    Villalona-Calero, Miguel
    Byrd, John C.
    Marcucci, Guido
    BLOOD, 2008, 112 (11) : 1016 - 1016