This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.
At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.
≥18 years old and ≤70 years old, male or female;
Patients with haploid peripheral blood stem cell transplantation of AML;
All patients received BU based myeloablative conditionings;
Blood routine: neutrophils ≥1×10^9/L, platelet ≥50.0×10^9/L;
Those who are allergic to known azacitidine or interferon
Patients with active acute GVHD;
Patients with moderate or more chronic GVHD;
Non-haploid donor transplants;