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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.
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.
Enrollment
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Volunteers
Inclusion criteria
Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:
Age between 18 and 70 years
ECOG performance status ≤ 2
Adequate organ function defined as:
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
Primary purpose
Allocation
Interventional model
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6 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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