Lymphoma Clinical Trial
Official title:
A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas
This is a pilot clinical trial investigating the addition of haploidentical natural killer
cell infusion to autologous stem cell transplantation. This intervention will be evaluated in
children with high-risk solid tumors for whom autologous transplantation is indicated.
Natural killer cells from a haploidentical family member will be given after high dose
chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma,
the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic
cell recovery will be evaluated and survival of children treated with this approach will be
determined.
The investigators expect to enroll 36 participants. Haploidentical family members (donors)
will also be recruited to provide natural killer cells.
Primary Objective:
- To evaluate day +35 ANC engraftment in autologous stem cell transplantation for high
risk pediatric malignancies after stem cell selection and immunotherapy.
Secondary Objectives
- To estimate incidence of relapse, disease-free survival and overall survival.
- To characterize lymphocyte and hematopoietic reconstitution in these patients.
- To describe the characteristics of the stem cell and natural killer cell grafts.
- To estimate the overall survival of patients treated without stem cell manipulation or
NK cell infusion due to off therapy criteria
;
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