Relapsed/Refractory Paediatric Acute Leukaemia
Conditions
Keywords
Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
Brief summary
To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia
Interventions
BIOLOGICALActivated and expanded natural killer cells (NKAEs)
Activated and expanded natural killer cells (NKAEs) from haploidentical donor
Sponsors
Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 23 Years
Healthy volunteers
No
Inclusion criteria
1. Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or 2. Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2) 3. Lansky index \> 60% 4. Mild (\<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4). 5. Left ventricular ejection fraction \> 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).
Exclusion criteria
1. Patients with history of bad therapeutical compliance 2. Patients not valid after psycho-social evaluation 3. Positive HIV serology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia | 2 months after infusion | Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections | End of infusion and follow-up (2 months and 1 year) |
| Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune | End of infusion and follow-up (2 months and 1 year) |
| Objective response rate according to cytomorphic and by minimal residual disease criteria (cytometry and/or real time PCR) at the end of the treatment | End of infusion and follow-up (2 months and 1 year) |
| Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period. | End of infusion and follow-up (2 months and 1 year) |
Countries
Spain
Outcome results
None listed