Acute Myeloid Leukemia Clinical Trial

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

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.

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Full Description

In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In current formulations, the volume of plerixafor required to administer doses higher than 240 mcg/kg may result in significant discomfort with repeated daily injections. In this phase I extension study, we seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

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Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT01027923

Recruitment Status:

Terminated

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
St. Louis Missouri, 63110, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT01027923

Recruitment Status:

Terminated

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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