1. Name of trial drug: Mylotarg, CPX-351 (a novel drug which combines two anti-cancer drugs - cytarabine and daunorubicin in a new formulation)
  2. For what level of MDS severity risk: High (> 10% bone marrow blasts); also acute myeloid leukaemia
  3. What subtype of MDS: Intermediate – 2 or High Risk
  4. Aims and benefits: This trial is designed for adult patients aged 18 to 60 years but also for patients aged 60 years or over for whom intensive therapy is considered appropriate. It aims to answer several therapeutic questions including
    • To determine if a new dosing schedule of Mylotarg (two doses) is better than the current standard of a single dose.
    • Is survival improved by different chemotherapy regimens (eg. FLAG-Ida + Mylotarg vs DA + Mylotarg).
    • Is the novel drug CPX-351 better than FLAG-Ida when used in patients considered to be at high risk of relapse or in those found to have poor risk cytogenetics.
  5. Basic inclusion criteria:
    • Acute myeloid leukaemia or high risk Myelodysplastic Syndrome (>10% bone marrow blasts)
    • 18 years up to the age of 60, but patients over this age are eligible if intensive therapy is considered a suitable option.
    • Suitable for intensive chemotherapy
    • Adequate kidney function
  6. Basic exclusion criteria:
    • Patients who previously received demethylation treatment (eg. Azacitidine) for high risk MDS (>10% blasts)
    • Previous chemotherapy for acute myeloid leukaemia
    • Concurrent active malignancy excluding basal cell carcinoma
    • Pregnant or lactating
    • Known infection with human immunodeficiency virus (HIV)
  7. Trial sites/locations and name of physician in charge of trial: 
  8. More information:

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