Healthy Donor Study II - Comparing Plerixafor With G-CSF and Plerixafor

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nova Scotia Health Authority; Stephen Couban
• Collaborator: Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor

Criteria

The inclusion and exclusion criteria are designed to reflect those that are used in practice to choose appropriate normal healthy donors for allogeneic stem cell transplantation.

Inclusion Criteria:

• Male or female between the ages of 18 and 30

• Unable or unwilling to give written informed consent

• No history of cardiac, pulmonary, liver or renal disease

• Normal CBC, creatinine, liver enzymes, bilirubin, INR and PTT

Exclusion Criteria:

• Allergy to G or to E.coli-derived agents

• Allergy to "caine" type anesthetics

• Pregnancy or breast feeding

• BMI greater than 25 to avoid difficulty with the number of bone marrows performed

• Skin conditions, autoimmune disease, sickle cell disease or splenomegaly to avoid rare side effects of G-CSF

• Any subject, who in the opinion of the investigator, should not participate in this study