Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant
This clinical trial wants to study the safety, effectiveness and efficacy of NK cells incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Up to 2 years after first infusion
Reevaluation of the Minimal residual disease (MRD)
Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry
Time frame: Up to 1 year after first infusion
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