Phase I/II study on cytarabine and idarubicin combined with escalating doses of clofarabine in newly diagnosed patients with acute myeloid leukaemia and high risk for induction failure (AMLSG 17-10 CIARA trial)
Standard
Phase I/II study on cytarabine and idarubicin combined with escalating doses of clofarabine in newly diagnosed patients with acute myeloid leukaemia and high risk for induction failure (AMLSG 17-10 CIARA trial). / Krauter, Jürgen; Fiedler, Walter; Schlenk, Richard F; Paschka, Peter; Thol, Felicitas; Lübbert, Michael; Wattad, Mohammed; Verbeek, Mareike; Könecke, Christian; Neuhaus, Barbara; Papkalla, Armin; Kebenko, Maxim; Janning, Melanie; Döhner, Konstanze; Gaidzik, Verena I; Becker, Heiko; Greil, Christine; Reimer, Peter; Götze, Katharina S; Döhner, Hartmut; Ganser, Arnold; Heuser, Michael.
in: BRIT J HAEMATOL, Jahrgang 183, Nr. 2, 18.10.2018, S. 235-241.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Phase I/II study on cytarabine and idarubicin combined with escalating doses of clofarabine in newly diagnosed patients with acute myeloid leukaemia and high risk for induction failure (AMLSG 17-10 CIARA trial)
AU - Krauter, Jürgen
AU - Fiedler, Walter
AU - Schlenk, Richard F
AU - Paschka, Peter
AU - Thol, Felicitas
AU - Lübbert, Michael
AU - Wattad, Mohammed
AU - Verbeek, Mareike
AU - Könecke, Christian
AU - Neuhaus, Barbara
AU - Papkalla, Armin
AU - Kebenko, Maxim
AU - Janning, Melanie
AU - Döhner, Konstanze
AU - Gaidzik, Verena I
AU - Becker, Heiko
AU - Greil, Christine
AU - Reimer, Peter
AU - Götze, Katharina S
AU - Döhner, Hartmut
AU - Ganser, Arnold
AU - Heuser, Michael
N1 - © 2018 British Society for Haematology and John Wiley & Sons Ltd.
PY - 2018/10/18
Y1 - 2018/10/18
N2 - This open-label, multicentre phase I/II study determined the maximum tolerated dose (MTD), safety and efficacy of clofarabine administered with cytarabine and idarubicin in newly diagnosed acute myeloid leukaemia (AML) patients lacking favourable genetic aberrations. The MTD was 30 mg/m2 clofarabine for patients below and above 60 years. The most frequently reported grade 3-4 non-haematological adverse events were infectious and gastrointestinal toxicities. Complete remission (CR)/CR with incomplete recovery rate was 67%. Allogeneic haematopoietic cell transplantation in first remission was feasible in a high proportion of younger AML patients and probably contributed to the favourable outcome compared to historical controls.
AB - This open-label, multicentre phase I/II study determined the maximum tolerated dose (MTD), safety and efficacy of clofarabine administered with cytarabine and idarubicin in newly diagnosed acute myeloid leukaemia (AML) patients lacking favourable genetic aberrations. The MTD was 30 mg/m2 clofarabine for patients below and above 60 years. The most frequently reported grade 3-4 non-haematological adverse events were infectious and gastrointestinal toxicities. Complete remission (CR)/CR with incomplete recovery rate was 67%. Allogeneic haematopoietic cell transplantation in first remission was feasible in a high proportion of younger AML patients and probably contributed to the favourable outcome compared to historical controls.
KW - Journal Article
U2 - 10.1111/bjh.15546
DO - 10.1111/bjh.15546
M3 - SCORING: Journal article
C2 - 30378121
VL - 183
SP - 235
EP - 241
JO - BRIT J HAEMATOL
JF - BRIT J HAEMATOL
SN - 0007-1048
IS - 2
ER -