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)

Jürgen Krauter; Walter Fiedler; Richard F. Schlenk; Peter Paschka; Felicitas Thol; Michael Lübbert; Mohammed Wattad; Mareike Verbeek; Christian Könecke; Barbara Neuhaus; Armin Papkalla; Maxim Kebenko; Melanie Janning; Konstanze Döhner; Verena I. Gaidzik; Heiko Becker; Christine Greil; Peter Reimer; Katharina S. Götze; Hartmut Döhner; Arnold Ganser; Michael Heuser

doi:10.1111/bjh.15546

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)

Jürgen Krauter^*, Walter Fiedler, Richard F. Schlenk, Peter Paschka, Felicitas Thol, Michael Lübbert, Mohammed Wattad, Mareike Verbeek, Christian Könecke, Barbara Neuhaus, Armin Papkalla, Maxim Kebenko, Melanie Janning, Konstanze Döhner, Verena I. Gaidzik, Heiko Becker, Christine Greil, Peter Reimer, Katharina S. Götze, Hartmut DöhnerArnold Ganser, Michael Heuser

^*Corresponding author for this work

Clinic of Hematology and Oncology

2 Citations (Scopus)

Abstract

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.

Original language	English
Journal	British Journal of Haematology
Volume	183
Issue number	2
Pages (from-to)	235-241
Number of pages	7
ISSN	0007-1048
DOIs	https://doi.org/10.1111/bjh.15546
Publication status	Published - 10.2018

Funding

We thank all patients for their participation in the study. We thank Hannover Clinical Trial Centre (HCTC) and Gabriele Samson for coordinating the study. This study was supported in part by Sanofi Genzyme and DFG grant HE 5240/6-1.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Krauter, J., Fiedler, W., Schlenk, R. F., Paschka, P., Thol, F., Lübbert, M., Wattad, M., Verbeek, M., Könecke, C., Neuhaus, B., Papkalla, A., Kebenko, M., Janning, M., Döhner, K., Gaidzik, V. I., Becker, H., Greil, C., Reimer, P., Götze, K. S., ... Heuser, M. (2018). 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). British Journal of Haematology, 183(2), 235-241. https://doi.org/10.1111/bjh.15546

@article{d1698c6364604260bfe812071826e112,

title = "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)",

abstract = "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.",

author = "J{\"u}rgen Krauter and Walter Fiedler and Schlenk, \{Richard F.\} and Peter Paschka and Felicitas Thol and Michael L{\"u}bbert and Mohammed Wattad and Mareike Verbeek and Christian K{\"o}necke and Barbara Neuhaus and Armin Papkalla and Maxim Kebenko and Melanie Janning and Konstanze D{\"o}hner and Gaidzik, \{Verena I.\} and Heiko Becker and Christine Greil and Peter Reimer and G{\"o}tze, \{Katharina S.\} and Hartmut D{\"o}hner and Arnold Ganser and Michael Heuser",

note = "Publisher Copyright: {\textcopyright} 2018 British Society for Haematology and John Wiley \& Sons Ltd",

year = "2018",

month = oct,

doi = "10.1111/bjh.15546",

language = "English",

volume = "183",

pages = "235--241",

journal = "British Journal of Haematology",

issn = "0007-1048",

publisher = "John Wiley and Sons Inc",

number = "2",

}

Krauter, J, Fiedler, W, Schlenk, RF, Paschka, P, Thol, F, Lübbert, M, Wattad, M, Verbeek, M, Könecke, C, Neuhaus, B, Papkalla, A, Kebenko, M, Janning, M, Döhner, K, Gaidzik, VI, Becker, H, Greil, C, Reimer, P, Götze, KS, Döhner, H, Ganser, A & Heuser, M 2018, '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)', British Journal of Haematology, vol. 183, no. 2, pp. 235-241. https://doi.org/10.1111/bjh.15546

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. et al.
In: British Journal of Haematology, Vol. 183, No. 2, 10.2018, p. 235-241.

Research output: Journal Articles › Journal articles › Research › peer-review

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

PY - 2018/10

Y1 - 2018/10

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.

UR - https://www.scopus.com/pages/publications/85055637687

U2 - 10.1111/bjh.15546

DO - 10.1111/bjh.15546

M3 - Journal articles

C2 - 30378121

AN - SCOPUS:85055637687

SN - 0007-1048

VL - 183

SP - 235

EP - 241

JO - British Journal of Haematology

JF - British Journal of Haematology

IS - 2

ER -

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)

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