Acute myeloid leukemia MedDRA version: 18.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: NK cells diferenciated adult allogeneic haploidentical ofexpanded periferic blood and activated with
Pharmaceutical Form: Injection
INN or Proposed INN: NK cells diferenciated adult allo
Sponsors
Antonio Pérez Martínez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged between 0 and 21 years diagnosed with AML in first cytologic remission who have completed induction and consolidation chemotherapy phase, and do not comply criteria for allogeneic HSCT. That is, patients who have responded well to induction lacking HLA identical related donor and have high-risk cytogenetic abnormalities 2. Lansky / Karnofsky index > 60%. 3. Functional disorders of organs (liver, kidney, respiratory) mild-moderate ( 39% . 5. Grant informed consent in accordance with current legislation . 6. Presence of a haploidentical donor. Are the trial subjects under 18? yes Number of subjects for this age range: 35 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a history of poor compliance. 2. Patients who after a psycho-social assessment are censored as unfit for the procedure: • psycho-social situation that makes it impossible proper participation in the study. • Patients with disease secondary to emotional or psychological problems such as PTSD, phobias, delusions, psychosis, with support request by specialists. • Evaluation of the involvement of the family in the patient's health. • Inability to understand information about the trial. 3. Severe alteration of functional organs (liver, kidney, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3). 4. Contraindications, interactions, precautions for use and dose reductions indicated in the corresponding summary of product characteristics should be considered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduce by 20% the probability of relapse at three years of pediatric patients with AML in first cytologic remission , without good prognosis cytogenetic alterations and without indication of progenitors hematopoietic allogeneic transplant.;Secondary Objective: 1. To determine the in vitro susceptibility of myeloid blasts to Natural Killer lymphocytes allogeneic. 2. To determine the safety of infusion of NK cells along with the chemotherapy regimen.;Primary end point(s): The main endpoint is the probability of relapse in patients after infusion of NK cells. Each patient will be monitored according to clinical guidelines for detecting relapse. For evaluation, bone marrow aspirate will be performed after a month of treatment and subsequently at least annually, to complete three years of follow-up. The objective response rate will be set according to the criteria and cytomorphologic "minimal residual disease" (cytometry and / or real-time PCR).;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The secondary endpoint will be the safety of infusion of NK cells along with the chemotherapy regimen. Patients will be monitored to detect potential adverse effects. For the NCI-CTC assessment criteria will be V4.0 and the proportion of patients with toxicity depending on the degree will be determined. Toxic effects can not be classified according to the criteria for toxicity of that system, they shall be classified as follows (MedDRA classification): a) Mild (asymptomatic); b) Moderate (symptom but does not significantly interfere with the function); c) Severe (causes significant interference function); d) life-threatening. 2. HLA typing of patient and donor, haplotyping KIR functionality donor and donor NK leukemia patient. 3. hematopoietic chimerism after infusion of NK cells. The expression of ligands for receptors activatorios (MICA, MICB, ULBPs) and inhibitory receptors (HLA-I) of NK cells was determined by multiparametric flow cytometry. 4. The in vitro cytotoxic activity of NK cells against allogeneic leukemic blasts be another measured variable Eur real time fluorescence-TDA (Blomberg et al. J Immunol Methods 1986).;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Spain
Contacts
Public ContactUCICEC
Hospital Universitario La Paz
Outcome results
None listed