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

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Acute Myeloid LeukemiaLeukemiaMyeloid Leukemia
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)

Trial Locations (6)

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

29011

Hospital Materno-Infantil de Málaga, Málaga

30120

Hospital de la Arrixaca, Murcia

48903

Hospital Universitario de Cruces, Barakaldo

06010

Hospital Materno Infantil de Badajoz, Badajoz

All Listed Sponsors
collaborator

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

collaborator

Fundación Mutua Madrileña

OTHER

lead

Instituto de Investigación Hospital Universitario La Paz

OTHER

NCT02763475 - NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents | Biotech Hunter | Biotech Hunter