Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors
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
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.
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