Plerixafor for Stem Cell Mobilization in Normal Donors

NCT ID: NCT01818284

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Blood And Marrow Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Filgrastim + Plerixafor

Each donor receives Filgrastim 5 µg/kg subcutaneously in the morning daily for 4 days. The dose of Filgrastim based on the donor's actual body weight. Donors will continue Filgrastim until completion of apheresis. Each donor receives Plerixafor 240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization. The dose-volume of Plerixafor based on the donor's actual body weight. Apheresis procedure to start the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor. The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor.

The apheresis procedure may continue beyond day 1 until the target dose of 4x106 cluster of differentiation 34 (CD34+) cells/kg (recipient's weight) is obtained.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

5 µg/kg in the morning daily for 4 days.

Plerixafor

Intervention Type: DRUG

240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization.

Apheresis Procedure

Intervention Type: PROCEDURE

The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor.

The apheresis procedure may continue beyond day 1 until the target dose of 4x106 CD34+ cells/kg (recipient's weight) is obtained.

Interventions

Filgrastim

5 µg/kg in the morning daily for 4 days.

Intervention Type: DRUG

Plerixafor

240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization.

Intervention Type: DRUG

Apheresis Procedure

The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor.

The apheresis procedure may continue beyond day 1 until the target dose of 4x106 CD34+ cells/kg (recipient's weight) is obtained.

Intervention Type: PROCEDURE

Other Intervention Names

Neupogen; Granulocyte-colony stimulating factor; G-CSF; GCSF; CSF-3; Mobozil

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Proteonomix, Inc.

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chitra M. Hosing, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2013-02209

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-0579

Identifier Type: -

Identifier Source: org_study_id