NCT00990054

Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase I, Dose Escalation Study of Plerixafor in Combination With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Plerixafor	240 mcg/kg/dose and proceeding to escalating dose levels for determination of the single-dose maximum tolerated dose (MTD) provided that there are no unacceptable dose limiting toxicities

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-10-06
• Last updated: 2015-03-24

Locations

8 sites across 1 country: United States