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ACUTE MYELOID LEUKEMIA

High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial

Leukemia volume 39, pages 1857–1864 (2025)Cite this article

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Abstract

Whether adding anthracycline to intermediate- or high-dose cytarabine as consolidation is beneficial remains unclear in acute myeloid leukemia (AML). Eligible AML patients in first complete remission were randomly assigned (1:1) to receive either high-dose cytarabine with idarubicin (IA3 + 3) (idarubicin 10 mg/m2, d1-3 and cytarabine 2 g/m2, every 12 h, d1-3) or high-dose cytarabine (HDAC) (cytarabine 3 g/m2, every 12 h, d1-3) regimens as first consolidation. The primary endpoint was the rate of negative measurable residual disease (MRD−) after first consolidation. Between November 2018 and December 2021, 407 patients were assigned to IA3 + 3 (n = 204) or HDAC (n = 203) groups. MRD− after first consolidation for IA3 + 3 and HDAC groups was 65.2% (95%CI: 58.6–71.8%) and 53.2% (46.3–60.1%) (P = 0.009). The 3-year cumulative incidence of relapse was 22.6% (95%CI :16.8–29.0%) and 34.0% (27.1–41.1%) (P = 0.014), DFS was 68.4% (61.5–75.3%) and 52.9% (45.4–60.5%) (P = 0.003), OS was 75.5% (69.0–82.1%) and 69.6% (62.4–76.7%) (P = 0.18) and treatment-related mortality was 8.8% (5.2–13.6%) and 13.0% (8.5–18.5%) (P = 0.23) in two groups, respectively. Eighty-seven (43%) and 114 (56%) patients underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), respectively (P = 0.006). IA3 + 3 regimen results in deeper remissions and reduces relapse compared to HDAC. This deeper remission improves DFS and translates into treatment advantage, with fewer patients undergoing allo-HSCT. (ClinicalTrials.gov, NCT03620955).

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Fig. 1: Trial profile.
Fig. 2: The rate of MRD negativity after first consolidation.
Fig. 3: Relapse and survival analysis.
Fig. 4: Cytogenetic and molecular response.

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Data availability

De-identified individual participant data that underlie the results reported in this article and the study protocol will be made available beginning 9 months and ending 36 months after publication. Requests for data will be assessed by an independent review committee on a case-by-case basis. Data will be made available to investigators whose proposed use of the data has been approved. After 36 months, participant data will be available on request to the corresponding author and after de-identification, as per the moderated access approach of the data repository unit at Southern Medical University, Guangzhou, China.

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Acknowledgements

The authors thank all the faculty members and patients that participated in this study. This work was supported by the National Key Research and Development Program of China (2021YFC2500300-4 to QFL, 2022YFC2502600-5 to LX), the Major Project of the National Natural Science Foundation of China (82293634 to QFL), the National Natural Science Foundation of China (82170213 to LX) and the Science and Technology Program of Guangdong Province (2023B110007 to QFL).

Author information

Author notes

  1. These authors contributed equally: Yu Zhang, Zinan Feng, Jing Du, Hui Liu, Sijian Yu, Xinquan Liang, Weihua Zhao, Qing Zhang, Xiong Zhang.

Authors and Affiliations

  1. Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China

    Yu Zhang, Zinan Feng, Jing Du, Hui Liu, Sijian Yu, Guopan Yu, Pengcheng Shi, Qianwei Liu, Ruoyang Shao, Min Dai, Xuejie Jiang, Dan Xu, Fen Huang, Zhiping Fan, Na Xu, Ren Lin, Hua Jin, Jing Sun, Qifa Liu & Li Xuan

  2. Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, China

    Yu Zhang, Zinan Feng, Jing Du, Hui Liu, Sijian Yu, Guopan Yu, Pengcheng Shi, Qianwei Liu, Ruoyang Shao, Min Dai, Xuejie Jiang, Dan Xu, Fen Huang, Zhiping Fan, Na Xu, Ren Lin, Hua Jin, Jing Sun, Qifa Liu & Li Xuan

  3. Department of Hematology, The First People’s Hospital of Chenzhou, Chenzhou, China

    Xinquan Liang

  4. Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China

    Weihua Zhao & Meiqing Wu

  5. Department of Hematology, Guangdong Second Provincial General Hospital, Guangzhou, China

    Qing Zhang

  6. Department of Hematology, Maoming People’s Hospital, Maoming, China

    Xiong Zhang

  7. Department of Hematology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China

    Danian Nie

  8. Department of Hematology, Shenzhen Hospital, Southern Medical University, Shenzhen, China

    Zhiqiang Sun

  9. Peking Department of Hematology and Shenzhen Bone Marrow Transplantation Public Service Platform, Shenzhen Second People’s Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, China

    Xin Du

  10. Department of Hematology, The Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen, China

    Xiaojun Xu

  11. Department of Hematology, The Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, China

    Hong Qu

  12. Department of Hematology, Foresea Life Insurance Guangzhou General Hospital, Guangzhou, China

    Wenjie Xiong

  13. Department of Hematology, The First People’s Hospital of Guangzhou, Guangzhou, China

    Shunqing Wang

  14. Department of Hematology, Dongguan People’s Hospital, Affiliated Dongguan People’s Hospital of Southern Medical University, Dongguan, China

    Yirong Jiang

  15. Department of Hematology, Peking University Shenzhen Hospital, Shenzhen, China

    Hongyu Zhang

  16. Department of Hematology, Zhongshan City People’s Hospital, Zhongshan, China

    Ziwen Guo

  17. Department of Hematology, Hunan Provincial People’s Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, China

    Can Liu

  18. Beijing Lu Daopei Institute of Hematology, Beijing, China

    Qifa Liu

Authors
  1. Yu Zhang
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  2. Zinan Feng
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  3. Jing Du
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  4. Hui Liu
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  36. Li Xuan
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Contributions

LX, QFL, and YZ designed the clinical trial. YZ, ZNF, JD, HL, SJY, XQL, WHZ, QZ, XZ, DNN, ZQS, XD, XJX, GPY, PCS, QWL, RYS, HQ, WJX, SQW, YRJ, HYZ, ZWG, MD, XJJ, DX, FH, ZPF, NX, CL, MQW, RL, HJ, JS, QFL, and LX wrote the manuscript, collected the data. ZNF and QWL did the statistical analysis. QFL, XQL, QZ, XZ, DNN, WHZ, ZQS, XD, XJX, HQ, WJX, SQW, YRJ, HYZ, ZWG, and CL led the trial within each institute. All authors contributed patients, provided clinical data, reviewed, and approved the final draft.

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Correspondence to Qifa Liu or Li Xuan.

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Zhang, Y., Feng, Z., Du, J. et al. High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial. Leukemia 39, 1857–1864 (2025). https://doi.org/10.1038/s41375-025-02655-x

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