Protocol
INFT2: HLA - Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less than 2 Years of Age with Hematologic Malignancies
Diseases
Leukemias / Lymphomas : Leukemias (high risk hematologic malignancies)
Description
Hematologic malignancies (blood cell cancers) in very young children are hard to treat with standard doses of chemotherapy (anti-cancer drugs). Stem cell transplantation (infusion of healthy blood forming cells) has been used but has not always been successful. The best donor of stem cells is a sibling (brother or sister) who is a match (the sibling’s cells match the subject’s immune type, or HLA type). But few very young children with leukemia have a matched sibling donor. This research study is for those children who do not have a matched sibling donor.
In this study, a parent will be the stem cell donor. Using a parent donor (a parent donor is a partial match for the subject’s HLA type) increases the risk of graft-versus-host disease (GVHD). GVHD occurs when the donor cells (the graft) recognize that the body tissues of the child (the host) are different. Because severe GVHD can be life-threatening, the parent’s stem cells will be filtered using a machine called the CliniMACS system, which removes the cells that cause GVHD. This system has not been approved by the Food and Drug Administration (FDA) and is considered experimental.
In addition to the stem cell transplant, parent donor natural killer (NK) cells will be given. NK cells are special cells in the immune system (the body organs and cells that defend the body against infection and disease) that target cancer cells. NK cells may help donor cells to grow and may reduce the chance of GVHD.
In this experimental treatment, chemotherapy will be used in addition to the stem cell and NK cell transplants. It is unknown if these treatments will work better than the treatments now being used to treat very young children with hematologic malignancies.
Objectives
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To study the outcome of very young subjects treated with stem cell and NK cell transplant one year after treatment
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To find out what factors affect the outcome of very young subjects treated with stem cell and NK cell transplant
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To find out the effects (good and bad) of treatment with stem cell and NK cell transplant
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To study the blood cells in the bone marrow before and after treatment with stem cell and NK cell transplant
Eligibility
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Subjects must be equal to or less than 24 months of age at time of transplant
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Subjects must have a parent who is able to be a stem cell donor
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Subjects must have adequate cardiac (heart), pulmonary (lung), renal (kidney), and hepatic (liver) function
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
Contact
Wing Leung, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-521-9005
Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.