Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte
colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both
healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via
apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008,
Plerixafor received approval from the Food and Drug administration for use in combination
with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is
not designed to support approval of a new indication or change in the advertising for
Plerixafor. The route of administration and dosage level are identical to that which is
listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins
Lymphoma, there is no known or theoretic increased risk of the use of this drug in this
patient population.
The study hypothesis for this study is that patients with a circulating CD34+ count < 20
cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X
10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.