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

Phase 2

Completed

• Conditions: Relapsed/Refractory Paediatric Acute Leukaemia
• Interventions: Biological: Activated and expanded natural killer cells (NKAEs)

• Registration Number: NCT02074657
• Lead Sponsor: Hospital Universitario La Paz

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Study Start: 2014-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activated natural killer cells	Activated and expanded natural killer cells (NKAEs)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections	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)

Trial Locations

Locations (2)

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Infantil Universitario La Paz; 🇪🇸 Madrid, Spain