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NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents

NCT02763475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-10-05

No results posted yet for this study

Summary

The main goal of this study is to evaluate the anti-relapse prophylactic activity of inoculating Natural Killer (NK) cells as consolidation therapy of acute myeloid leukemia in paediatric patients with cytologic remission. The patients included have intermediate risk of relapse and no indication for allogeneic hematopoietic stem cell transplantation.

After the standard induction and consolidation chemotherapy treatment, patients will receive five days of fludarabine to try to kill any minimal residual disease and prevent NK cell rejection. Two different NK cells infusions will be performed within one week (day 0 and 7). Interleukin 2 (IL-2) will be administrated to increase the cytotoxic activity of NK cells.

Conditions

Interventions

DRUG

cyclophosphamide

60mg/kg by vein on day -6

DRUG

Fludarabine

25mg/m2 iv daily on day -5 to -1

PROCEDURE

NK cell infusion

* First allogeneic haploidentical NK cell iv. infusion: 5x10e7/kg, NK CD3-CD56+ immunophenotype, 24-48h after chemotherapy * Second allogeneic haploidentical NK cell iv. infusion: up to 5x10e8/kg, NK CD3-CD56+immunophenotype, 7 days after the first infusion.

DRUG

IL-2

1x10\^6 UI/m2 three times a week for two weeks from first NK infusion (day 0)

Sponsors & Collaborators

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    collaborator OTHER

  • Fundación Mutua Madrileña

    collaborator OTHER

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763475 on ClinicalTrials.gov