This is a phase I study designed to test the safety of oral clofarabine when given as consolidation therapy to older patients with AML in remission.
The prognosis of acute myeloid leukemia (AML) in patients 60 and older is dismal with traditional therapy. Several factors contribute to the poor prognosis of older individuals, including the increased incidence of the multidrug resistance efflux pump, comorbidities and unfavorable cytogenetics. The recently reported AML-13 and ALFA trials suggest that less intense consolidation in this population is at least equivalent to more intense, induction style efforts. Clofarabine is a next generation nucleoside analogue that was designed to optimize the favorable attributes of fludarabine and cladribine, while minimizing toxicity. The intravenous formulation has shown considerable activity in older patients with AML who have been considered either unfit for or unlikely to benefit from conventional therapy. Additionally, clofarabine has an oral formulation that patients may find more acceptable for consolidation therapy rather than multiple courses of intravenous medications, administered over several days. This study is designed as a traditional 3x3 phase I trial with the intention of defining the maximum tolerated dose of oral clofarabine consolidation for older patients with AML in remission.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Washington University
St Louis, Missouri, United States
Maximum tolerated dose (MTD) and dose limiting toxicity (DLT)
Time frame: DLT - 1st cycle (28 days), MTD - completion of 1st cycle by all patients in all cohorts
Adverse events by grade and attribution
Time frame: Start of treatment through 30 days post-last dose
Disease-free survival
Time frame: Every 6 months for 3 years
Overall survival
Time frame: Every 6 months for 3 years
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