Clinical trial NCT01818284: Plerixafor for Stem Cell Mobilization in Normal Donors
Official title: Plerixafor for Stem Cell Mobilization in Normal Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blood And Marrow Transplantation
Keywords: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Proteonomix, Inc.
First posted: 2013-03-26
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs to be performed.

Researchers will study if using both drugs lowers the risk of the stem cell transplant recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's body.

The safety and effectiveness of this drug combination will also be studied.

Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from the bone marrow to the blood.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC)
timeFrame: 5 days
measure: Feasibility in Mobilizing PBPC in Donors: Number of Donors Reaching Stem Cell Target Collection on First Day of Collection Following Treatment of Filgrastim Plus Plerixafor
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Chitra M. Hosing, MD
role: PRINCIPAL_INVESTIGATOR
References: