The purpose of this study is to find out the highest safe dose and examine the side effects and effectiveness of eltrombopag olamine in patients with acute myeloid leukemia (AML) treated with chemotherapy that have not responded to previous therapy or have suffered a relapse
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and examine the tolerability of daily oral eltrombopag (eltrombopag olamine) (14 days +/- 2 days after initiation of cytarabine) in patients receiving high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemia patients with hypoplastic bone marrow 14 days +/- 2 days from initiation of cytarabine. II. To examine platelet count recovery to \>= 100 x 10\^9/L when eltrombopag is administered following high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemic patients. OUTLINE: This is a dose-escalation study. Patients receive eltrombopag olamine orally (PO) once daily (QD) from day 1 up to day 62. Treatment continues for up to 9 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Given PO
Receive standard care
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
MTD and tolerability of eltrombopag olamine in patients with AML, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: Up to day 15
Platelet count recovery to >= 100 x 10^9/L when eltrombopag olamine is administered following high dose cytarabine and mitoxantrone for the treatment of AML patients
Time frame: Up to 9 weeks
Platelet recovery to >= 100 x 10^9/L and platelet response, assessed based on a modified International Working Group Consensus Criteria for hematologic improvement
Number of platelet transfusions and duration of time without platelet transfusions from the first dose of eltrombopag olamine will be measured.
Time frame: Up to 9 weeks
Platelet response based on a modified International Working Group Consensus Criteria for hematologic improvement
Time frame: Up to 9 weeks
Platelet transfusion requirements
Time frame: Up to 9 weeks
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