Study protocol for a phase II, multicentre, prospective, non-randomised clinical trial to assess the safety and efficacy of infusing allogeneic activated and expanded natural killer cells as consolidation therapy for paediatric acute myeloblastic leukaemia.

Introduction: Acute myeloblastic leukaemia (AML) constitutes the second most common haematological malignancy in the paediatric population. Current treatment regimens are based on the administration of polychemotherapy, combining high doses of cytarabine with anthracyclines and topoisomerase inhibitors. Allogeneic haematopoietic stem cell transplantation (HSCT) is an option for high-risk patients with AML (and for intermediate-risk patients if a sibling donor is available).

Beyond CAR-T cells: Natural killer cells immunotherapy.

Children and adolescents suffering from refractory leukaemia, relapse after stem cell transplantation, solid metastatic tumour or refractory to conventional treatments still condition a dismal prognosis. The critical role of the immune system in the immunosurveillance of cancer is becoming relevant with the development of new treatments such as the checkpoint inhibitor drugs and genetic modified T lymphocytes, tisagenlecleucel or axicabtagene ciloleucel. In addition, other immunotherapies are being developed such as cell therapy with natural killer (NK) lymphocytes.

Physical Activity in Pediatric Cancer patients with solid tumors (PAPEC): trial rationale and design.

Background: This randomized controlled trial on Physical Activity in Pediatric Cancer (PAPEC) was designed to assess the impact of an exercise program on pediatric cancer patients undergoing chemotherapy for solid tumors.

Methods And Design: 60 pediatric patients of both sexes, aged 4 to 18 years and undergoing treatment for extracranial primary solid tumors will be recruited for this trial. Each participant will be randomly assigned (with blocking on sex) to either an intervention or control (normal care) group.