Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkin's Disease
Participants with HD who have been treated with cyto-reductive chemotherapy, who are to
undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria
are eligible to enter this study. The only changes to the standard of care is the addition
of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis and the
collection of blood samples for pharmacokinetic (PK) analysis and pharmacodynamics (PD)
analysis by CD34+ fluorescence-activated cell sorting (FACS) analysis. Blood samples for PK
and CD34+ FACS analyses will be obtained prior to and after the first dose of plerixafor.
Participants will undergo mobilization with G-CSF (10 µg/kg daily) and will receive
plerixafor (240 µg/kg) on each day prior to apheresis. Participants will be apheresed for
up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6
cells/kg). After apheresis, all participants will be treated with high dose chemotherapy in
preparation for transplantation. Participants will be transplanted with cells obtained from
the G-CSF plus plerixafor mobilization regimen. In the event that a sufficient number of
cells for transplantation are not obtained from the collection, cells may be retained and
pooled for transplantation at the investigator's discretion.
The primary endpoint is the proportion of HD participants who collect ≥5*10^6 CD34+ cells/kg
with this mobilization regimen. The secondary endpoints include the safety of this
mobilization regimen, the proportion of participants who collect ≥2*10^6 CD34+ cells/kg, the
change in CD34+ cells circulating in the peripheral blood after a dose of plerixafor, and
the number of days of apheresis required to obtain ≥5*10^6 CD34+ cells/kg. In addition,
success of the transplantation will be evaluated by measuring the time to engraftment of
PMNs and PLTs. Participants will be followed for 12 months to assess transplant durability.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.
Day 5 up to Day 9
United States: Food and Drug Administration
|Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia||St Louis, Missouri 63110-1093|