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

NCT01403896 | Completed Phase 2

• 1 other identifier: SC001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Lymphoma, Stem Cell Type

Keywords

Hematopoietic Stem Cell Transplantation; Plerixafor; Healthy Donors; Stem Cell Graft

Outcome Measures

Primary Outcomes (1)

• The frequency of CD34+ and CD34+CD38- cells at different time points as compared to baseline.

  The frequency of CD34+ and CD34+CD38- cells in a graft has been show to be an excellent measure of hematopoietic engrafting potential.

  Day -1, 0, +1

Secondary Outcomes (2)

• 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.

  Day -1, 0, +1

• The frequency of CD56bright NK cells at different time points as compared to baseline

  Day -1, 0, +1

Study Arms (2)

Plerixafor Group

ACTIVE COMPARATOR

Drug: Plerixafor (Mozobil)

Plerixafor + G-CSF group

EXPERIMENTAL

Drug: Plerixafor + G-CSF

Interventions

Plerixafor (Mozobil) DRUG

They will receive Plerixafor (240 µg/kg/day subcutaneously for 1 dose) on Day 0 at 8 am

Also known as: Mozobil, AMD 3100

Plerixafor Group

Plerixafor + G-CSF DRUG

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

Also known as: Mozobil, AMD 3100, Neupogen

Plerixafor + G-CSF group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stephen Couban: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Capital Health District Authority

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Lymphoma

Interventions

plerixafor; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Stephen Couban

  CDHA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hematologist

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 27, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

CA (1)