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Low-dose Decitabine Priming With Intermediate-dose Cytarabine Followed By Umbilical Cord Blood Infusion As Consolidation Therapy For Elderly Patients With Acute Myeloid Leukemia:a Phase Ⅱ Single-arm Study

Posted on:2020-05-31Degree:DoctorType:Dissertation
Country:ChinaCandidate:X Y LiFull Text:PDF
GTID:1484306188453704Subject:Internal medicine (hematology)
Abstract/Summary:
Treatment of acute myeloid leukemia(AML)in elderly patients remains as a great challenge.In this prospective single arm study(ChiCTR-OPC-15006492),we evaluate the efficacy and safety of a novel consolidation therapy with low-dose decitabine(LD-DAC)priming with intermediate-dose cytarabine(ID-Ara-C)followed by umbilical cord blood(UCB)infusion in elderly patients with AML.A total of 25 patients with a median age of 64 years(60~74)who achieved complete remission(CR)after induction chemotherapy were enrolled into the study.The 1-year actual overall survival(OS)rate and leukemia-free survival(LFS)was 88.0%and 76.0%,respectively.The hematological and non-hematological toxicity were mild to moderate with only one patient died in remission due to infection with possible acute graft versus host disease(aGVHD).When compared to a concurrent cohort of patients receiving conventional consolidation,the study group tends to have an improved OS and LFS(p=0.03 and 0.086 respectively)while the toxicity was comparable between two groups.In conclusion,this study suggested that the novel combination of LD-DAC,ID-Ara-C and UCB infusion might be an optimal consolidation therapy for elderly patients with AML and prospective phase Ⅲ randomized study is warranted to confirm this observation.
Keywords/Search Tags:Elderly patients, Acute Myeloid Leukemia, Decitabine, Umbilical Cord Blood
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