Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Arms (1)

1. type

   EXPERIMENTAL

   label

   Clofarabine + Cytarabine + Decitabine

   description

   Clofarabine 20 mg/m\^2 by vein (IV) as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m\^2 as a 1- to 2-hour infusion daily for 5 days.

   interventionNames

   1. Drug: Clofarabine
   2. Drug: Cytarabine
   3. Drug: Decitabine

Primary outcomes (4)

1. measure

   Disease-free (DFS) or Relapse-free Survival (RFS) Time

   timeFrame

   Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.

   description

   Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.