Spots Global Cancer Trial Database for Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS

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Trial Identification

Brief Title: Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS

Official Title: Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study

Study ID: NCT04166929

Conditions

Acute Myeloid Leukemia

Myelodysplasia

Interventions

Haplo SCT with NK cells

Haplo SCT

Study Description

Brief Summary: Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML. Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.

Detailed Description: