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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antonio Pérez Martínez; Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Fundación Mutua Madrileña; Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Instituto de Investigación Hospital Universitario La Paz
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

1. 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.

2. Karnofsky or Lansky Performance Scale (PS) > 60%

3. Mild-moderate (<4) organ functional impairment (liver, kidney, respiratory) according to the criteria of the National Cancer Institute (NCI CTCAE v4).

4. Left ventricular ejection fraction> 39%

5. Adult subjects who have voluntarily signed informed consent before the first study intervention.

6. Minor subjects whose representative / legal guardian has voluntarily signed informed consent before the first study intervention.

7. 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.

8. 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.

9. Presence of a haploidentical donor

Exclusion Criteria:

1. Patients with a history of poor treatment compliance

2. 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.

3. Severe (4) organ functional impairment (liver, kidney, respiratory) according to the criteria of the National Cancer Institute (NCI CTCAE v4).

4. They should be considered contraindications, interactions, precautions for use and dose reductions indicated in the respective data sheets.

5. Subjects who have been administered other investigational drugs within 90 days prior to inclusion