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

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Stephen Couban, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT01403896
First received: July 14, 2011
Last updated: July 31, 2017
Last verified: July 2017
  Purpose

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.


Condition Intervention Phase
Malignant Lymphoma, Stem Cell Type Drug: Plerixafor (Mozobil) Drug: Plerixafor + G-CSF Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Stephen Couban, Nova Scotia Health Authority:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Actual Study Start Date: April 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Mozobil
  • AMD 3100
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
Other Names:
  • Mozobil
  • AMD 3100
  • Neupogen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403896

Locations
Canada, Nova Scotia
Capital Health District Authority
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Stephen Couban
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Stephen Couban CDHA
  More Information

Responsible Party: Stephen Couban, Hematologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01403896     History of Changes
Other Study ID Numbers: SC001
Study First Received: July 14, 2011
Last Updated: July 31, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephen Couban, Nova Scotia Health Authority:
Hematopoietic Stem Cell Transplantation
Plerixafor
Healthy Donors
Stem Cell Graft

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2017