Healthy Donor Study II - Comparing Plerixafor With G-CSF and Plerixafor
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.
|Malignant Lymphoma, Stem Cell Type||Drug: Plerixafor (Mozobil) Drug: Plerixafor + G-CSF||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study To Design a Clinical Trial That Will Compare the Ability of Plerixafor Alone Versus Plerixafor Plus G-CSF To Generate a Bone Marrow Versus Blood Transplant Product In Normal Healthy Adults|
- The frequency of CD34+ and CD34+CD38- cells at different time points as compared to baseline. [ Time Frame: Day -1, 0, +1 ]The frequency of CD34+ and CD34+CD38- cells in a graft has been show to be an excellent measure of hematopoietic engrafting potential.
- The frequency of CD56bright NK cells, CD4+ central memory T-cells, perforin+ CD8+ T-cells and CD19+ CD27-TLR9+ B-cells at different time points as compared to baseline. [ Time Frame: Day -1, 0, +1 ]Relative frequencies of CD56bright NK cells, CD4+ central memory T-cells, perforin+ CD8+ T-cells, and CD19+ CD27-TLR9+ B-cells has been associated with GVHD.
- The frequency of CD56bright NK cells at different time points as compared to baseline [ Time Frame: Day -1, 0, +1 ]A high frequency of CD56bright NK cells in the stem cell graft has been associated with low leukemia relapse.
|Actual Study Start Date:||April 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Plerixafor Group||
Drug: Plerixafor (Mozobil)
They will receive Plerixafor (240 µg/kg/day subcutaneously for 1 dose) on Day 0 at 8 am
|Experimental: Plerixafor + G-CSF group||
Drug: Plerixafor + G-CSF
They will receive G-CSF (5 µg/kg/day) for 4 days (Days -4,-3,-2,-1 at 8 am) followed by Plerixafor (240 µg/kg/day subcutaneously for 1 dose) on Day 0 at 8 am
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01403896
|Canada, Nova Scotia|
|Capital Health District Authority|
|Halifax, Nova Scotia, Canada|
|Principal Investigator:||Stephen Couban||CDHA|