IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)

Stopped early · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

Key facts

Study ID

NCT01027923

Run by

Washington University School of Medicine

People needed

6

Starts

2010-05-01

Expected to finish

2011-09-01

Last updated by the study team

2015-01-26

Who can join

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

You may qualify if…

• Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:
• Primary refractory disease following ≥ 1 round of induction chemotherapy
• First relapse or higher
• Age between 18 and 70 years
• ECOG performance status ≤ 2
• Adequate organ function defined as:
• Creatinine ≤ 1.5 x institutional ULN
• AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
• ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
• Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
• Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
• Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
• 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 ≥ 50 x 103 /mm3
• Active CNS involvement with leukemia
• Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
• Pregnant or nursing
• Concurrently receiving any other investigational agent
• Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
• Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
• Severe concurrent illness that would limit compliance with study requirements

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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