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A Pilot Study of AMD3100 as a Sensitizing Agent in Myeloablative Allogeneic Blood and Marrow Transplantation for Chemotherapy Resistant Pediatric Acute Leukemia


Phase 1
2 Years
22 Years
Open (Enrolling)
Both
Pediatric Acute Myeloblastic Leukemia, Relapsed, Pediatric Acute Lymphoblastic Leukemia, Relapsed

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Trial Information

A Pilot Study of AMD3100 as a Sensitizing Agent in Myeloablative Allogeneic Blood and Marrow Transplantation for Chemotherapy Resistant Pediatric Acute Leukemia


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

AMD3100 safety

Outcome Description:

Incidence of grade 3 and 4 regimen-related toxicity assessed per Bearman scale at day 42. Patients in dose level 1 get 3 days of AMD3100. If 2 cases of grade 4 toxicity or 3 cases of grade 3-4 toxicity occur, dose level 1 and study will be closed. Otherwise, after 6 patients have been assessed at day 42, the dose will be escalated to 5 days of AMD3100 (dose level 2). If 2 cases of grade 4 toxicity or 3 cases of grade 3-4 toxicity occur, the study will be closed. Otherwise, after 6 patients have been enrolled at this level the study will be closed to enrollment.

Outcome Time Frame:

day 42 after bone marrow transplant

Safety Issue:

Yes

Principal Investigator

Kuang-Yueh Chiang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Food and Drug Administration

Study ID:

CHOA AMD3100 Pilot

NCT ID:

NCT01655875

Start Date:

June 2012

Completion Date:

June 2020

Related Keywords:

  • Pediatric Acute Myeloblastic Leukemia, Relapsed
  • Pediatric Acute Lymphoblastic Leukemia, Relapsed
  • Allogeneic Blood and Marrow Transplantation
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Children's Healthcare of AtlantaAtlanta, Georgia  30342