To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz
Madrid, Madrid, Spain
Safety profile (number of AEs per patient)
Time frame: Two months
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Time frame: During 14 months
time to hematological recovery (days)
hematological recovery: neutrophils \>500/mm3, lymphocytes \>250/mm3 and platelets \>50.000/mm3)
Time frame: 2 months
days of hospitalization in each cycle
Time frame: 2 months
Objective response rate
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)
Time frame: 2 months
days of isolation
Time frame: 2 months
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