atural Killer cell infusion as consolidation therapy in children and adolescents with acute myelogenous leukemia.

Antonio Pérez Martínez0 个研究点开始时间: 2015年11月5日最近更新: 2016年5月17日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Antonio Pérez Martínez