Protocol

    NKEXP: Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors

    Diseases

    Leukemias / Lymphomas : Refractory or relapsed leukemia (AML, T-ALL, CML, JMML), T-cell lymphoma, myelodysplastic syndrome, Ewing sarcoma (ESFT), rhabdomyosarcoma (RMS)

    Description

    This research study will evaluate a new treatment of infusing donor natural killer (NK) blood cells in patients with relapsed or  refractory leukemia, lymphoma or solid tumors. NK cells are a type of lymphocyte/white blood cell that has been found to attack viruses and “kill” some cancer cells.  This study will review the safety of infusing (giving by vein) NK cells obtained from a family member in children and young adults with cancer. Before these NK cells are infused, they will be “expanded” in a laboratory at St. Jude Children’s Research Hospital. Expanding the donor cells means the cells will be stimulated to increase in number and ability to kill cancer cells.

    This research study involves two parts or “phases” as follows: Phase I: where a blood test called “expansion evaluation” that will determine if a family member is able to be an NK cell donor and Phase II: which includes NK cell collection, expansion and processing. If a donor is able to donate their NK cells and if the NK cells expand, the recipient patient will be infused with the donor NK cells. The NK collection and expansion process will take approximately 1 month. This study requires the participant and his/her caregiver to stay in or near Memphis for at least 90 days after the NK cell infusion for bone marrow testing on or about 1, 2 and 3 months after the study infusion. A final test will be done 1 year after NK cell infusion time point. The scheduled tests or evaluations are always subject to change (be done more or less often than noted) due to the participant’s medical condition.


    Objectives


    Eligibility for Recipients


    Eligibility for Donors


    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

    David Shook, MD
    St. Jude Children’s Research Hospital
    332 North Lauderdale
    Memphis, TN 38105  USA
    Voice:   1-866-2ST-JUDE  (1-866-278-5833)
    FAX:     901-595-4011

    Referring or consulting physicians only: protocolinfo@stjude.org

    For all other inquiries about St. Jude Children's Research Hospital: 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.