Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.

Key facts

Study ID

NCT00906945

Run by

Washington University School of Medicine

People needed

39

Starts

2011-02-01

Expected to finish

2015-09-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
• Primary refractory disease following no more than 2 cycles of induction chemotherapy
• First relapse with no prior unsuccessful salvage chemotherapy
• Age between 18 and 70 years old
• ECOG performance status ≤ 3
• Adequate organ function defined as:
• Calculated creatinine clearance ≥ 50 ml/min
• AST, ALT, total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
• Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
• Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
• Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
• Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
• Able to provide signed informed consent prior to registration on study

You may not qualify if…

• Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
• Peripheral blood blast count ≥ 20 x 103 /mm3
• Active CNS involvement with leukemia
• Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
• Pregnant or nursing
• Received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
• Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
• Severe concurrent illness that would limit compliance with study requirements

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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