ANK-2: activated and expanded NK cell immunotherapy together with salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia

Phase 1

Conditions: Relapsed/refractory acute leukaemia
MedDRA version: 17.0Level: LLTClassification code 10000831Term: Acute leukaemia NOSSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005146-38-ES

Lead Sponsor: ANTONIO PEREZ MARTINEZ

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients betweem 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, postransplant relapse or refractary, or
2. Patients betweem 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion critaria 1 or 2)
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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with a history of poor treatment compliance.
2. Patients following a psycho-social assessment are censored as unfit for the procedure.
3. Functional impairment of organs (liver, kidney, respiratory) severe (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3).
4. Positive HIV serology.
5. Should be considered contraindications, interactions, precautions for use and dose reductions indicated in the respective data sheets.