Overview

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:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Treatments:
JM 3100
Plerixafor
Criteria
Inclusion Criteria:

- Must have chemotherapy-resistant acute leukemia (primary refractory or relapsed and
refractory AML, ALL, undifferentiated, bi-lineage or mixed lineage leukemia)

- Participant must have a well HLA matched related, mismatched related or unrelated
marrow donor with whom the patient is allele matched at at least 7 of 8 HLA loci or a
single unrelated cord blood unit matched at at least 4 of 6 HLA loci with minimal dose
of 4x10(7)NC/Kg

Exclusion Criteria:

- Prior allogeneic or autologous hematopoietic stem cell transplantation

- Prior exposure to AMD3100

- Active central nervous system leukemia

- Uncontrolled viral, bacterial, fungal, protozoal infection

- HIV infection

- Does not meet standard organ function for transplant