LANK-2: Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia

Study Overview
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Brief Summary
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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

Official Title
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LANK-2: Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia

Conditions
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Relapsed/Refractory Paediatric Acute Leukaemia

Intervention / Treatment
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* Biological: Activated and expanded natural killer cells (NKAEs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or 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) Lansky index > 60% Mild (<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4). Left ventricular ejection fraction > 39% To grant informed consent in accordance with the current legal regulations. Presence of a compatible haploidentical donor (father or mother or brother). Exclusion Criteria: Patients with history of bad therapeutical compliance Patients not valid after psycho-social evaluation Positive HIV serology

Ages Eligible for Study
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Maximum Age: 23 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: Activated natural killer cells<br> | Biological: Activated and expanded natural killer cells (NKAEs)<br>* Activated and expanded natural killer cells (NKAEs) from haploidentical donor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia | Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability | 2 months after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells