Feasibility, safety, effectiveness and toxicity of Post-transplant Expanded, Activated Haploidentical Natural Killer Cells Infusion in Haploidentical Hematopoietic Stem Cell Transplantation for Pediatric Patients with Acute Myeloid Leukemia: A Pilot Study

Tehran University of Medical Sciences0 个研究点目标入组 5 人开始时间: 待定最近更新: 2023年5月1日

适应症

试验速览

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•Age = 18 years old.
•Patients must have a diagnosis of AML other than acute promyelocytic leukemia (APL) according to WHO criteria and should be a candidate for their first allogenic haploidentical HSCT.
•All patients must have adequate organ function defined as:a.Renal Function: Age-adjusted serum creatinine = to 1.5 x normal for age/gender OR creatinine clearance or GFR greater than or equal to 60 cc/min/1.73m2b.Liver Function: Total bilirubin = 1.5 x normal for age, AND Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal and Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.c.Cardiac Function: Normal ejection fraction documented by either echocardiogram or radionuclide MUGA evaluation OR Normal fractional shortening documented by echocardiogramd.Pulmonary Function: No dyspnea at rest, no oxygen requirement.
•Karnofsky or Lansky performance score of greater than or equal to 50.
•Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation
•At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.

•Pregnancy: Quantitative Serum B-HCG must be negative in girls who are post-menarchal
•Breast feeding women are not eligible.
•Active or uncontrolled infection
•Patient declines participation

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