A Phase 2 interventional study of haploidentical stem cell transplantation and NK cell therapy in Neuroblastoma, Ewing Sarcoma and Rhabdomyosarcoma, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: haploidentical stem cell transplantation and NK cell therapy
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
Time frame: within 30 days after transplantation
event-free survival and overall survival
efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors
Time frame: 3 years after transplantation
number of patients developing GVHD
Time frame: up to 1 year
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center