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

NCT ID: NCT02074657

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-09-30

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

Detailed Description

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Conditions

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Relapsed/Refractory Paediatric Acute Leukaemia

Keywords

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Immunotherapy NKAEs Expanded haploidentical natural killer cells Activated natural killer cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Activated natural killer cells

Group Type EXPERIMENTAL

Activated and expanded natural killer cells (NKAEs)

Intervention Type BIOLOGICAL

Activated and expanded natural killer cells (NKAEs) from haploidentical donor

Interventions

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Activated and expanded natural killer cells (NKAEs)

Activated and expanded natural killer cells (NKAEs) from haploidentical donor

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
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
Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Antonio Pérez Martínez

MD, Servicio de Hemato-Oncología Pediátrica

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Pérez-Martínez, MD, PhD

Role: STUDY_CHAIR

Hospital Infantil Universitario La Paz

Locations

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Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Infantil Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Vela M, Corral D, Carrasco P, Fernandez L, Valentin J, Gonzalez B, Escudero A, Balas A, de Paz R, Torres J, Leivas A, Martinez-Lopez J, Perez-Martinez A. Haploidentical IL-15/41BBL activated and expanded natural killer cell infusion therapy after salvage chemotherapy in children with relapsed and refractory leukemia. Cancer Lett. 2018 May 28;422:107-117. doi: 10.1016/j.canlet.2018.02.033. Epub 2018 Feb 23.

Reference Type DERIVED
PMID: 29477379 (View on PubMed)

Other Identifiers

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2012-005146-38

Identifier Type: -

Identifier Source: org_study_id