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BMC Cancer
Published in: BMC Cancer 1/2019

Open Access 01-12-2019 | Acute Myeloid Leukemia | Research article

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

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

Published in: BMC Cancer | Issue 1/2019

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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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Metadata
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
Authors
Xiaoyang Li
Yuexin Dong
Ya Li
Ruibao Ren
Wen Wu
Hongming Zhu
Yunxiang Zhang
Jiong Hu
Junmin Li
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2019
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-019-5975-8

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