To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Activated and expanded natural killer cells (NKAEs) from haploidentical donor
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Infantil Universitario La Paz
Madrid, Madrid, Spain
To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability
Time frame: 2 months after infusion
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Time frame: End of infusion and follow-up (2 months and 1 year)
Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune
Time frame: End of infusion and follow-up (2 months and 1 year)
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment
Time frame: End of infusion and follow-up (2 months and 1 year)
Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period.
Time frame: End of infusion and follow-up (2 months and 1 year)
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