Randomized study with a run-in feasibility phase to assess the added value of Clofarabine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS ≥ 1.5)
Phase of Trial: Phase III
Latest Information Update: 17 Nov 2015
At a glance
- Drugs Clofarabine (Primary) ; Amsacrine; Cytarabine; Idarubicin
- Indications Acute biphenotypic leukaemia; Acute myeloid leukaemia; Myelodysplastic syndromes
- Focus Adverse reactions; Registrational; Therapeutic Use
- 10 Jun 2017 Biomarkers information updated
- 07 Jul 2012 Planned number of patients changed from 800 to 880, actual initiation date (25 Jan 2010) and additional trial location (Belgium) added as reported by European Clinical Trials Database.
- 07 Jul 2012 Status changed from planning to recruiting as reported by European Clinical Trials Database.