Relapsed/refractory acute leukaemia MedDRA version: 17.0 Level: LLT Classification code 10000831 Term: Acute leukaemia NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: NK cells
Pharmaceutical Form: Injection
INN or Proposed INN: Células NK diferenciadas adultas alogénicas haploidénticas de sangre periférica expandidas y activadas con IL-15
Other descri
Sponsors
ANTONIO PEREZ MARTINEZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients betweem 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, postransplant relapse or refractary, or 2. Patients betweem 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion critaria 1 or 2) 3. Lansky index > 60% 4. Mild ( 39% 6. To grant informed consent in accordance with the current legal regulations. 7. Presence of a compatible haploidentical donor (father or mother or brother). Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 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 treatment compliance. 2. Patients following a psycho-social assessment are censored as unfit for the procedure. 3. Functional impairment of organs (liver, kidney, respiratory) severe (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3). 4. Positive HIV serology. 5. Should be considered contraindications, interactions, precautions for use and dose reductions indicated in the respective data sheets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of mature peripheral blood haploidentical expanded and activated IL-15 stimulated NK cells (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia;Secondary Objective: Analyze incidence of episodes of febrile neutropenia, bacteremia, infections (viral and fungal), hematological recovery and days of hospitalization. Evaluate complete remission rate (cytomorphological and by criteria of "minimal residual disease", flow cytometry and/or molecular biology) . Assess immune reconstitution of lymphocytes and cytotoxic activity of NK cells pre and post NKAES infusion.;Primary end point(s): Safety of mature peripheral blood haploidentical expanded and activated IL-15 stimulated NK cells infusion after chemotherapy;Timepoint(s) of evaluation of this end point: 2 months after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections 2. Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle 3. Immune reconstitution: Median of T-cell , B, NK, NKT and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during post-treatment follow-up period 4. In vitro cytotoxic activity of NK cells of the patient measured by real-time fluorescence-TDA Eur compared with that of the donor (Blomberg et al. J Immunol Methods 1986) 5. Objective response rate according to cytomorphologic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment ;Timepoint(s) of evaluation of this end point: 1. after each cycle 2. after each cycle 3. weekly 4. weekly 5. after treatment | — |
Countries
Spain
Contacts
Public ContactCLINICAL RESEARCH DEPARTMENT
APICES SOLUCIONES
Outcome results
None listed