Oral Clofarabine for Acute Myeloid Leukemia
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Oral Clofarabine Consolidation in Adults Aged 60 and Older With Acute Myeloid Leukemia|
- Maximum tolerated dose and dose limiting toxicity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Adverse events by grade and attribution [ Time Frame: Continuous throughout study ] [ Designated as safety issue: Yes ]
- Disease-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||October 2015|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Clofarabine 1-5 mg po on days 1 to 14-21 of a 28 day cycle for up to 5 cycle.
Other Name: Clolar
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.
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Camille N. Abboud, M.D.||Washington Univerisity|