Study of Oral Clofarabine Plus Low-dose Cytarabine in Previously Treated AML and High-Risk MDS Patients at Least 60 Years of Age
I. To estimate the maximum tolerated dose (MTD) of oral clofarabine when given with LDAC
(cytarabine) in patients age >= 60 with previously treated AML or high risk MDS.
I. To determine the response rate, disease-free survival (DFS), and overall survival (OS)
after therapy with oral clofarabine and LDAC for previously treated AML or high-risk MDS.
OUTLINE: This is a phase I, dose-escalation study of clofarabine followed by a phase II
Patients receive clofarabine orally (PO) once daily (QD) on days 1-5 and low-dose cytarabine
subcutaneously (SC) twice daily (BID) on days 1-10 or SC QD on days 1-14. Treatment repeats
every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up every 3 months for 2 years and
then annually for 3 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, according to the National Cancer Institute (NCI) Common Terminology Criteria v3.0, as assessed by the MTD of clofarabine when given together with cytarabine
Dose limiting toxicity (DLT) consists of grade 3-4 non-hematologic toxicity at least possibly related to study drug. Exceptions include neutropenic fever; drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin recovering to < grade 2 by 7 days. Prolonged grade 2 myelosuppression lasting longer than 49 days in patients who don't proceed to additional cytotoxic therapy is considered a DLT. The MTD or recommended phase II dose is the highest dose level at which no more than 1 patient out of 6 experiences DLT.
Occurring by day 30
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
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