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 KrauterWalter FiedlerRichard F SchlenkPeter PaschkaFelicitas TholMichael LübbertMohammed WattadMareike VerbeekChristian KöneckeBarbara NeuhausArmin PapkallaMaxim KebenkoMelanie JanningKonstanze DöhnerVerena I GaidzikHeiko BeckerChristine GreilPeter ReimerKatharina S GötzeHartmut DöhnerArnold GanserMichael HeuserPublished in: British journal of haematology (2019)
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.
Keyphrases
- newly diagnosed
- end stage renal disease
- acute myeloid leukemia
- ejection fraction
- chronic kidney disease
- clinical trial
- prognostic factors
- peritoneal dialysis
- randomized controlled trial
- rheumatoid arthritis
- stem cells
- squamous cell carcinoma
- intensive care unit
- high dose
- stem cell transplantation
- patient reported outcomes
- cell therapy
- hepatitis b virus
- copy number
- gene expression
- liver failure
- systemic lupus erythematosus
- acute lymphoblastic leukemia
- phase ii