Plerixafor for Stem Cell Mobilization in Normal Donors

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Proteonomix, Inc.
• Treatments: JM 3100; Lenograstim; Plerixafor; Sargramostim

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.