Acute Myeloid Leukemia Stem Cell Transplant Study – Phase II Pilot

Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia

Protocol Description

This Children’s Oncology Group Phase II Pilot study is about improving the methods used to perform tissue typing of potential unrelated bone marrow donors for young patients with acute myeloid leukemia (AML). Specifically the study explores whether specific bone marrow mismatches may improve bone marrow stem cell transplantation results. Stem cell transplantation can be an effective treatment for patients whose AML has relapsed or with difficult-to-treat AML, but finding compatible donors, based on current matching techniques, can often be difficult. Researchers believe that patients may have a better chance of survival if they receive stem cells from bone marrow donors whose marrow has a different type of KIR, a protein found on immune system cells that fight infections and cancerous cells.

Study Level: Phase II Pilot

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from one month of age to 21 years, who have been diagnosed with AML that has relapsed or is refractory and whose doctors have recommended an unrelated donor stem cell transplant because a related donor is not available or has been deemed unsuitable.
Males: Ages 1 month to 21 years
Females: Ages 1 month to 21 years

Participants and up to 5 potential donors will be tested for a protein known as KIR. Participants will receive a 10-day high-dose course of chemotherapy to destroy cells in the bone marrow. After the stem cell transplant is done, patients will receive 6 months of post transplant treatments followed by up to 12 months of tests.
Visits: Requires admittance for treatments
Duration: Up to 18 months for follow-up tests, but patients will be followed for up to 5 years

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study AAML05P1)
National Cancer Institute

Additional Resources
Children's Oncology Group CureSearch
Study Description at National Institutes of Health

Primary Investigator(s)

Rakesh Goyal, MD

Contact Information

To get started, please contact:
Jill Visnich, CRA

Last Update
February 17, 2014
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Last Update
February 17, 2014