Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Fase I/II, Unicentric, Historical Control Clinical Trial 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

Conditions
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ACUTE LEUKEMIA

Intervention / Treatment
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* Biological: Donor IL-15 stimulated NK cells infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical Assessable disease by analytic, molecular or image techniques. Comorbidity Sorror index less than 6. Give informed consent according to the legal requirements. Dispose of a donor without exclusion criteria. Exclusion Criteria: Positive HIV serology. Patients with an active infection or other underlying serious medical statement. Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study. Participation of any other interventional clincal trial within 30 days of planned enrollment into this study. Women who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NK cells infusion<br>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 | Biological: Donor IL-15 stimulated NK cells infusion<br>* DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |