AMD3100 for Sensitizing in Allogeneic Blood or Marrow Transplant for Chemotherapy Resistant Pediatric Acute Leukemia
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 2 - 22 |
| Updated: | 5/3/2014 |
| Start Date: | June 2012 |
| End Date: | June 2020 |
| Contact: | Sindy Midoro |
| Email: | sindy.midoro@choa.org |
| Phone: | 404-785-1441 |
A Pilot Study of AMD3100 as a Sensitizing Agent in Myeloablative Allogeneic Blood and Marrow Transplantation for Chemotherapy Resistant Pediatric Acute Leukemia
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.
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.
The first six patients will receive three daily doses of AMD3100 (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.
AMD3100 is given in combination with a standard pre-transplant conditioning regimen (total
body irradiation, etoposide and cyclophosphamide.) AMD3100 causes healthy bone marrow cells
to be released from the bone marrow into the blood so that they can be collected in patients
who will have peripheral (blood stream) blood stem cell transplants. AMD3100 also pushes out
leukemia cells from the bone marrow. Research in animals and in test tubes shows that the
bone marrow partially protects leukemia cells from chemotherapy and radiation. AMD3100 could
make leukemia treatments better by pushing out the leukemia cells from the bone marrow and
making them more sensitive to treatment. Clinical trials combining AMD3100 with normal doses
of chemotherapy are being done for relapsed acute leukemia. Researchers hope AMD3100 can be
given with conditioning regimen safely without causing more side effects. Up to 12
participants will be enrolled and estimated accrual duration is 2 years.
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.
AMD3100 is given in combination with a standard pre-transplant conditioning regimen (total
body irradiation, etoposide and cyclophosphamide.) AMD3100 causes healthy bone marrow cells
to be released from the bone marrow into the blood so that they can be collected in patients
who will have peripheral (blood stream) blood stem cell transplants. AMD3100 also pushes out
leukemia cells from the bone marrow. Research in animals and in test tubes shows that the
bone marrow partially protects leukemia cells from chemotherapy and radiation. AMD3100 could
make leukemia treatments better by pushing out the leukemia cells from the bone marrow and
making them more sensitive to treatment. Clinical trials combining AMD3100 with normal doses
of chemotherapy are being done for relapsed acute leukemia. Researchers hope AMD3100 can be
given with conditioning regimen safely without causing more side effects. Up to 12
participants will be enrolled and estimated accrual duration is 2 years.
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
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