Clinical Trials Directory

Trials / Terminated

TerminatedNCT01076270

Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from the bone marrow to the blood so they can be collected and stored. PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for mobilization of donor peripheral blood stem cells before a peripheral blood stem cell transplant in treating patients with hematologic malignancies

Detailed description

PRIMARY OBJECTIVES: I. The percentage of normal donors who collect at least 2 x 10\^6 CD34 cells/kg recipient weight on day 1 after administration of combined filgrastim and plerixafor. SECONDARY OBJECTIVES: I. Measuring CD34+ cells/ul in peripheral blood of donors 11, 15, 24 and 36 hours post dosing. II. Tolerance and safety of combined filgrastim and Plerixafor in normal donors. III. Engraftment of filgrastim/plerixafor mobilized stem cells in allogeneic recipients. IV. Acute and chronic graft-versus-host disease (GVHD) following the use of filgrastim/plerixafor mobilized stem cells. V. Yield of CD34+ cells based on donor weight. OUTLINE: Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation.

Conditions

Interventions

TypeNameDescription
DRUGplerixaforGiven SC
BIOLOGICALfilgrastimGiven SC
PROCEDUREperipheral blood stem cell transplantationInfusion of peripheral blood stem cells
PROCEDUREallogeneic hematopoietic stem cell transplantationInfusion of hematopoietic stem cells

Timeline

Start date
2010-06-01
Primary completion
2011-01-01
Completion
2011-02-01
First posted
2010-02-26
Last updated
2017-06-28
Results posted
2017-03-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01076270. Inclusion in this directory is not an endorsement.