AMD3100 for Sensitizing in Allogeneic Blood or Marrow Transplant for Chemotherapy Resistant Pediatric Acute Leukemia
Status:
Terminated
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
This study is for patients 2-21 years old who have acute leukemia that has not responded well
to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of
AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard
pre-transplant conditioning regimen (total body irradiation, etoposide and cyclophosphamide).
The conditioning regimen is the treatment that is given just before the transplant. This
treatment kills leukemia cells as well as healthy bone marrow and immune cells. Researchers
want to learn more about how AMD3100 affects acute leukemia cells. Blood and bone marrow
samples from study participants will be collected to find out if AMD3100 is making patients'
cells more sensitive to the conditioning regimen and to find out how it does this.
The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that
three doses do not significantly increase the side effects of transplant conditioning, the
investigators will give a second group of six patients five daily doses.