Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to determine if plerixafor can make cells more
sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to
as "7+3" that is commonly used in treating acute myeloid leukemia (AML). In this study,
plerixafor is used with treatments cytarabine and daunorubicin and with and without
granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they
tolerate the use of these drugs together and how well they work to treat the leukemia.
The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor
dosing schedule (once daily [QD] or twice daily [BID]), and/or recommended phase 2 dose
(RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in
combination with cytarabine and daunorubicin, and with and without granulocyte-colony
stimulating factor (G-CSF)