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

ANTONIO PEREZ MARTINEZ0 个研究点开始时间: 2012年11月12日最近更新: 2016年10月3日

适应症

试验速览

暂无简介。

•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

•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.

发起方

ANTONIO PEREZ MARTINEZ