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  • Title: 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.
    Author: Li X, Dong Y, Li Y, Ren R, Wu W, Zhu H, Zhang Y, Hu J, Li J.
    Journal: BMC Cancer; 2019 Aug 20; 19(1):819. PubMed ID: 31429724.
    Abstract:
    BACKGROUND: Treatment of acute myeloid leukemia (AML) in elderly patients remains a great challenge. In this prospective single arm study (ChiCTR-OPC-15006492), we evaluated 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. METHODS: A total of 25 patients with a median age of 64-years-old (60-74-years-old) who achieved complete remission (CR) after induction chemotherapy were enrolled in the study. RESULTS: The 2-year actual overall survival (OS) rate and leukemia-free survival (LFS) was 68.0 and 60.0%, respectively. The hematological and non-hematological toxicity were mild to moderate, and only one patient died in remission due to infection with possible acute graft versus host disease (aGVHD). Compared to a concurrent cohort of patients receiving conventional consolidation therapy, the study group tended to have an improved OS and LFS (p = 0.046 and 0.057, respectively), while the toxicity was comparable between the two groups. CONCLUSIONS: This study suggested the novel combination of LD-DAC, ID-Ara-C, and UCB infusion might be an optimal consolidation therapy for elderly patients with AML, and a prospective phase III randomized study is warranted to confirm this observation. TRIAL REGISTRATION: This single-arm phase II clinical trial in elderly AML patients was registered prospectively at www.chictr.org.cn (identifier: ChiCTR-OPC-15006492 ) on June 2, 2015.
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