High risk acute myeloid leukemia
Conditions
Interventions
Product Name: Células NK , diferenciadas, alogénicas, de sangre periférica, estimuladas con IL-15
Pharmaceutical Form: Infusion
INN or Proposed INN: Células NK , diferenciadas, alogénicas, de sangre
Sponsors
José Luís Díez Martín
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical 2. Assesable disease by analitic, molecular or image techniques. 3.Comorbility Sorror Index less than 6. 4.Give informed consent according to the legal requirements. 5. Dispose of a donor without exclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Possitive HIV serology. 2. Patients with an active infection or other underlying serious medical statement. 3. 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. 4. Participation of any other interventional clíncal trial within 30 days of planned enrollment into this study. 5.Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To establish the procedure safety. 2. To evaluate the inmunological reconstitution of the NK population, particularly the phenotype, genotype and functionality of the donor NK cells. 3. To compare the clinical evolution (overall survival, event-free survival) of the patients who receive NK IL-15 from the haploidentical donor with a historical control group of patients who have been undergone this kind of transplant in our site. 4. To evaluate the chimerism in lineage of NK cells to know exactly their kinetics. 5. To evaluate the dose-response in patients who receive NK IL-15. 6. To evaluate the inmunological reconstitution of the different lymphocyte population in patients who receive NK IL-15 infusion. 7. To evaluate the citotoxicity in Vitro of this cells facing a cell line (K562) or patient blasts if it were available.;Timepoint(s) of evaluation of this end point: Safety: all visits on the occurrence of possible adverse effects. events of relapse, death or EICR also recorded. Effectiveness: to evaluate the evolution of the underlying disease, following the usual protocol for the Department: SP chimerism in every 15 days of infusion of TPH, to complete chimerism SP molecular monitoring in those patients to be performed. Reassessment of disease with bone marrow study, cytological, residual disease by flow cytometry, and molecular genetic month, at 3 months (+100) and a year.;Main Objective: To evaluate safety and efectiveness of the NK cells exvivo incubated with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.;Primary end point(s): The main objective is to study the safety and efficacy of 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To compare the clinical outcome (overall survival, event-free survival) of patients receiving NK IL15 from his haploidentical donor, with a historical control group of our hospital patients with acute myeloid leukemia at high risk who have undergone this type of transplant. •Evaluate chimerism in NK cell lineage to know exactly kinetics of them. •Evaluate dose response in patients receiving IL NK 15. •Assess immune reconstitution of different lymphocyte populations in patients receiving infusion of NK IL15. •To evaluate the in vitro cytotoxicity of these cells facing a cell line (K562) or to blasts the patient if available.;Timepoint(s) of evaluation of this end point: Security: all visits on the occurrence of possible adverse effects. events of relapse, death or EICR also recorded. Effectiveness: to evaluate the evolution of the underlying disease, following the usual protocol for the Department: SP chimerism in every 15 days of infusion of TPH, to complete chimerism SP molecular monitoring in those patients to be performed. Reassessment of disease with bone marrow study, cytological, residual disease by flow cytometry, and molecular genetic month, at 3 months (+100) and a year. | — |
Countries
Spain
Contacts
Public ContactJosé Luís Diéz Martín
José Luís Diéz Martín
Outcome results
None listed