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Plerixafor for Stem Cell Mobilization in Normal Donors


Phase 2
10 Years
N/A
Not Enrolling
Both
Blood And Marrow Transplantation

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Trial Information

Plerixafor for Stem Cell Mobilization in Normal Donors


Donor:

Study Drug Administration:

On Days 1-5, you will receive filgrastim once a day through a needle under the skin. You
will either receive each dose from one of the nurses in the clinic, or you will be taught to
give it to yourself.

On Day 4, you will receive a dose of plerixafor through a needle under the skin around 8:00
P.M. in the Ambulatory Treatment Center (ATC). The exact time will depend on when you can
get your appointment in the ATC. Plerixafor will be given by one of the nurses in the
clinic. After you receive plerixafor, you will be watched for side effects in the clinic
for up to 30 minutes.

If your white blood cell count is too high on Day 4, you will not receive the dose of
plerixafor and will be taken off study.

You will have a central venous line (CVL) placed on the morning of Day 5 if the veins in
your arms are not large enough for stem cell collection. A CVL is a sterile flexible tube
that will be placed into a large vein while you are under local anesthesia. Your doctor
will explain this procedure to you in more detail, and you will be required to sign a
separate consent form.

Stem Cell Collection:

Around 8:00 A.M. on Day 5, some of your blood stem cells will be collected using a process
called apheresis. The apheresis process takes about 4 hours. You will be asked to sign a
separate informed consent for this procedure.

An apheresis machine will be connected to your CVL or to a needle and tube in your arm, and
your blood will be drawn. Your blood will flow through the machine, which removes stem cells
from the blood, and then will be returned back to you through another CVL or needle and tube
in your other arm. The stem cells that are collected will be frozen and stored until the
transplant.

If enough stem cells are not collected during the first apheresis procedure on Day 5, you
will keep receiving an injection of G-CSF every day, and you will have the apheresis
procedure repeated every day until enough cells are collected.

Study Tests:

- On Days 4 and 5, blood (about 1 tablespoon) will be drawn for routine tests and tests
to check for blood-forming cells.

- On Day 5, part of the stem cell sample that is collected (about 2 teaspoons) will be
sent to the lab of Dr. McNiece for research tests to study primitive stem cells (called
mesenchymal stem cells).

On Day 30, the study staff will call you on the telephone to check your health status.

Length of Treatment and Follow-up:

You will be on study for a total of 30 days after the injection of plerixafor. You may be
taken off study if you are unable to follow study directions, if you decide to leave the
study early, or if you cannot receive plerixafor because your white blood cell count is too
high after receiving filgrastim.

This is an investigational study. Filgrastim is FDA approved for use in stem cell
collection. Plerixafor is FDA approved for use in patients with multiple myeloma and
non-Hodgkin's lymphoma. Up to 30 donor and recipient pairs will take part in this study.
All will be enrolled at MD Anderson.

Recipient:

Stem Cell Transplant:

You will receive blood stem cells from a donor on this study. You will sign a separate
informed consent for the transplant procedure.

Follow-Up Visits:

About 1, 3, and 6 months after the transplant, an extra sample of bone marrow (about 2
teaspoons) will be collected at the same time as the standard of care bone marrow
aspiration/biopsy procedures. This bone marrow sample will be tested to find out how well
the donated stem cells have been accepted by your body. However, you will not have a
separate bone marrow aspiration/biopsy only to collect bone marrow for this testing.

When you return to the clinic at 6, 9, and 12 months for routine transplant follow-up
visits, the study staff will try to get information on your health status from the clinic
notes in your medical record. If this is not possible, you may receive a phone call from the
study staff to check your health status. These calls will last about 10 minutes.

Length of Treatment:

You will be on study for about 1 year after the transplant (including follow-up contact by
phone, if needed).

You may be taken off study early if you are not able to follow study directions or if you
decide to leave the study.

This is an investigational study. Filgrastim is FDA approved for use in stem cell
collection. Plerixafor is FDA approved for use in patients with multiple myeloma and
non-Hodgkin's lymphoma.

Up to 30 donor and recipient pairs will take part in this study. All will be enrolled at MD
Anderson.


Inclusion Criteria:



1. Donor eligibility: Age >/= 10 years.

2. Donor eligibility: Related donors who met standard eligibility criteria and are
willing to participate in this study.

3. Donor eligibility: Able to provide informed consent.

4. Recipient Eligibility: Patients who are scheduled to undergo an allogeneic related
transplant and whose donors consented to participate in this study.

5. Recipient Eligibility: Able to provide informed consent.

Exclusion Criteria:

1) Donors who are on anti-coagulation or anti-platelet agents are not eligible.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC)in Donors

Outcome Description:

Primary safety endpoint is development of any unexpected toxicity (any grade 3 or higher non-hematologic toxicity) in donors.

Outcome Time Frame:

5 days

Safety Issue:

Yes

Principal Investigator

Chitra M. Hosing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0579

NCT ID:

NCT01818284

Start Date:

August 2013

Completion Date:

Related Keywords:

  • Blood And Marrow Transplantation
  • Blood And Marrow Transplantation
  • Normal allogeneic donors
  • Stem cell mobilization
  • peripheral blood progenitor cells
  • PBPC
  • Allogeneic hematopoietic stem cell transplantation
  • HSCT
  • Donating blood stem cells
  • C-CSF
  • Neupogen
  • Filgrastim
  • Plerixafor
  • Mobozil
  • Apheresis

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030