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

Xiaoyang Li, Yuexin Dong, Ya Li, Ruibao Ren, Wen Wu, Hongming Zhu, Yunxiang Zhang, Jiong Hu, Junmin Li, Xiaoyang Li, Yuexin Dong, Ya Li, Ruibao Ren, Wen Wu, Hongming Zhu, Yunxiang Zhang, Jiong Hu, Junmin Li

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.

Keywords: Acute myeloid leukemia; Decitabine; Umbilical cord blood.

Conflict of interest statement

The authors declare that they have no competing interests.

Decitabine was provided free of charge by Chiatai Tianqing Pharma (China), which played no role in the study design, data collection, analysis, or writing of the manuscript.

Figures

Fig. 1
Fig. 1
a Leukemia-free survival according to treatment. The 2-year LFS was 60 and 37.5%, respectively, in the UCB and TCG group (p = 0.057). b Overall survival according to treatment. The 2-year OS was 68 and 45.8%, respectively, in the UCB and TCG group (p = 0.046)

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