Healthy Donor Study II - Comparing Plerixafor With G-CSF and Plerixafor
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Stem cells can be transplanted from a healthy donor to a patient to combat blood cancers and
other disorders. This process is called stem cell transplantation. Stem cells normally live
in the bone marrow. A bone marrow transplantation (BMT) is when the bone marrow is directly
transplanted into a patient. However, stem cells can also be stimulated to move from the bone
marrow to the blood where they can be collected, a process is called mobilization. When these
stem cells are transplanted it is called peripheral blood stem cell transplantation (PBSCT).
Both stem cell sources are used for different reasons, but PBSCT is much more common.
There is considerable debate as to which stem cell source, BMT or PBSCT, is optimal. There
are differences between the two sources in important transplant outcomes. The stem cell
product that is transplanted, also called the stem cell graft, contains more than just stem
cells. Results from studies suggest that the variation in the cells with grafts may account
for the variation in outcomes. Preliminary data from a recent study conducted by the Canadian
Blood and Bone Marrow Transplant Group has associated relative frequencies of particular cell
populations with leukemic relapse and another important outcome called graft versus host
disease (GVHD). While the later essentially equates to a failed transplant, the former is the
most common and devastating complication of stem cell transplantation.
The only drug used to mobilize stem cells into the blood of health donors for collection is
G-CSF. However there is a new mobilization drug recently approved called plerixafor. This
drug is able to mobilize stem cells when G-CSF has failed and pre-clinical studies suggest
that it may produce a superior stem cell graft to G-CSF alone. There is little information
available, besides safety and efficacy data, about the effects that plerixafor has on the
stem cell graft of normal healthy donors.
This study will compare the stem cell graft in normal healthy donors following plerixafor
mobilization versus plerixafor and G-CSF mobilization. Specifically, they will look at the
cell populations that have been previously correlated with important transplantation outcomes
like relapse and GVHD. The investigators suspect that the stem cell graft mobilized by
plerixafor and G-CSF will provide a superior graft to that mobilized by plerixafor alone.