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

Madrid Health Service

Status and phase: Completed; Phase 2

Conditions: Relapsed/Refractory Paediatric Acute Leukaemia

Treatments: Biological: Activated and expanded natural killer cells (NKAEs)

Study type: Interventional

Funder types: Other

Identifiers

NCT02074657

2012-005146-38

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: Under 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Activated natural killer cells

Experimental group

Treatment:

Biological: Activated and expanded natural killer cells (NKAEs)