Leukemia, Myeloid, Acute Clinical Trial
Official title:
Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.
Primary objective: rate of complete remission (morphologic complete remission or morphologic
complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of
this combination in induction therapy of older patients previously unexposed to intensive
chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction;
(4) 30- and 60-day mortality rate.
The treatment period will include up to 4 cycles of treatment (induction 1, induction 2,
consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will
be considered day 1.
- Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and
cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval
required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) >
1000 cells/L.
- Up to 2 cycles of consolidation treatment may be completed by eligible patients in
remission (morphologic complete remission or morphologic complete remission with
incomplete blood count recovery) if safety parameters are met.
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