NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents
Acute Myeloid Leukemia, Leukemia, Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Killer Cells, Natural, Consolidation treatment, cytologic remission, Haploidentical NK Cells, allogeneic, IL-2 Expanded NK Cells
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 0 and 21 years, diagnosed with AML in first cytological remission who have completed the induction and consolidation chemotherapy phases and no criteria for allogeneic hematopoietic stem cell transplantation (HSCT), ie patients who have responded well to induction lacking donor HLA identical relative and do not have high-risk cytogenetic abnormalities.
- Karnofsky or Lansky Performance Scale (PS) > 60%
- Mild-moderate (<4) organ functional impairment (liver, kidney, respiratory) according to the criteria of the National Cancer Institute (NCI CTCAE v4).
- Left ventricular ejection fraction> 39%
- Adult subjects who have voluntarily signed informed consent before the first study intervention.
- Minor subjects whose representative / legal guardian has voluntarily signed informed consent before the first study intervention.
- For mature minors (12 to 17 years old), in addition to the consent signed by the legal guardian, the assent of the child will be obtained.
- Women of childbearing potential must have a negative pregnancy test at the time inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, combined oral contraceptive with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) while participating in the study and 30 days after the last visit.
- Presence of a haploidentical donor
Exclusion Criteria:
- Patients with a history of poor treatment compliance
Patients who after a psycho-social assessment are censored as unfit for procedure:
- Socio-familiar situation that precludes proper participation in the study.
- Patients with emotional or psychological problems secondary to the illness such as PTSD, phobias, delusions, psychosis, requiring assistance by specialists.
- Evaluation of the involvement of the family in the patient's health.
- Inability to understand the information about the trial.
- Severe (4) organ functional impairment (liver, kidney, respiratory) according to the criteria of the National Cancer Institute (NCI CTCAE v4).
- They should be considered contraindications, interactions, precautions for use and dose reductions indicated in the respective data sheets.
- Subjects who have been administered other investigational drugs within 90 days prior to inclusion
Sites / Locations
- Hospital Universitario de Cruces
- Hospital Materno Infantil de Badajoz
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Hospital de la Arrixaca
- Hospital Materno-Infantil de Málaga
Arms of the Study
Arm 1
Experimental
Natural Killer (NK) Cells + Chemotherapy
Starting on day -6, 60mg/Kg cyclophosphamide by vein will be administrated. Day -5 to -1 fludarabine administrated by vein at 25 mg/m2. 24-48 hours after chemotherapy completion, NK cell infusion will be injected (day 0). On day 7 a second NK cell infusion will be administrated. First infusion consist of 5x10^7/kg NK CD3-CD56+ NK cells. The second NK cell infusion will include up to 5x10^8 CD3-CD56+ cells if no treatment related toxicity occurred. Subcutaneous IL-2 (1x10^6 UI/m2) three times a week for two weeks will be administrated after first NK infusion.