Infusion of cells to treat myeloblastic leuciemia

Phase 1

Conditions: Acute myeloid leukemia
MedDRA version: 18.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-001901-15-ES

Lead Sponsor: Antonio Pérez Martínez

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients aged between 0 and 21 years diagnosed with AML in first cytologic remission who have completed induction and consolidation chemotherapy phase, and do not comply criteria for allogeneic HSCT. That is, patients who have responded well to induction lacking HLA identical related donor and have high-risk cytogenetic abnormalities
2. Lansky / Karnofsky index > 60%.
3. Functional disorders of organs (liver, kidney, respiratory) mild-moderate (<4), according to the criteria of the National Cancer Institute (NCI CTCAE v4).
4. Left Ventricule ejection fraction> 39% .
5. Grant informed consent in accordance with current legislation .
6. Presence of a haploidentical donor.
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
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 compliance.
2. Patients who after a psycho-social assessment are censored as unfit for the procedure:
• psycho-social situation that makes it impossible proper participation in the study.
• Patients with disease secondary to emotional or psychological problems such as PTSD, phobias, delusions, psychosis, with support request by specialists.
• Evaluation of the involvement of the family in the patient's health.
• Inability to understand information about the trial.
3. Severe alteration of functional organs (liver, kidney, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3).
4. Contraindications, interactions, precautions for use and dose reductions indicated in the corresponding summary of product characteristics should be considered.