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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK cells infusion | Experimental | NK cells incubated infusion (CD56 +, CD3) ex vivo with IL-15 in patients with acute myeloid leukemia undergoing high-risk allogeneic haploidentical Pt-C donor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor IL-15 stimulated NK cells infusion | Biological | DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Up to 2 years after first infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Reevaluation of the Minimal residual disease (MRD) | Reevaluation of the Minimal residual disease (MRD) in bone marrow by flow cytometry | Up to 1 year after first infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
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