Clinical trial NCT01818284
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
Sponsor: M.D. Anderson Cancer Center
Start date: 2013-10-01; Completion date: 2016-06-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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.
Interventions: intervention 1: Filgrastim intervention 2: Plerixafor intervention 3: Apheresis Procedure
Intervention descriptions: intervention 1: 5 µg/kg in the morning daily for 4 days. intervention 2: 240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization. intervention 3: 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.

Protocol documents: