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

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; JM 3100; Mitoxantrone; Plerixafor

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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