Effect of stem cell infusion timing on acute graft-versus-host disease: a randomized clinical trial

  1. Yue Wu
  2. Jiayu Huang
  3. Yang Yang
  4. Weijie Cao
  5. Yanmin Zhao
  6. Yujun Dong
  7. Weiwei Wu
  8. Xiaoxia Hu
  9. Yang Cao
  10. Ran Zhang
  11. Congxiao Zhang
  12. Bingjie Wang
  13. Kaidi Song
  14. Guangyu Sun
  15. Wen Yao
  16. Qing Cheng
  17. Jian Wang
  18. Meijuan Tu
  19. Yiwen Hou
  20. Cheng Zhan
  21. Xiaoyu Zhu

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Abstract

BACKGROUND

Our previous retrospective study suggested that peripheral-blood stem-cell infusion before 2:00 p.m. was associated with a lower incidence of acute graft-versus-host disease (aGVHD) than later infusion, but retrospective analyses are susceptible to confounding. Whether infusion timing affects aGVHD has not been tested in a randomized trial.

METHODS

In this multicenter, open-label trial, we randomly assigned patients 12 to 60 years of age with hematologic malignancies undergoing a first allogeneic peripheral-blood stem-cell transplantation to stem-cell infusion at 12:00 pm (±30 minutes) or 6:00 pm (±30 minutes). The primary end point was grade II to IV aGVHD within 100 days after transplantation.

RESULTS

A total of 198 patients underwent randomization (99 in each group). Grade II to IV acute GVHD occurred in 11.1% of patients in the 12:00 pm group and 23.2% in the 6:00 pm group (subdistribution hazard ratio for 6:00 pm vs. 12:00 pm, 2.18; 95% CI, 1.06 to 4.48; P = 0.029). The corresponding incidences of grade III to IV acute GVHD were 2.0% and 12.2% (subdistribution hazard ratio, 6.25; 95% CI, 1.39 to 28.15; P = 0.006). There were no significant differences in hematopoietic recovery, TRM, or relapse between groups.

CONCLUSIONS

Among patients undergoing allogeneic peripheral-blood stem-cell transplantation, infusion at 12:00 pm resulted in a lower incidence of grade II to IV acute GVHD than infusion at 6:00 pm ( ClinicalTrials.gov number, NCT06294678 .)

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  1. PREreview

    This Zenodo record is a permanently preserved version of a Structured PREreview. You can view the complete PREreview at https://prereview.org/reviews/23248027.

    Does the introduction explain the objective of the research presented in the preprint? Yes
    Are the methods well-suited for this research? Somewhat inappropriate
    Are the conclusions supported by the data? Somewhat supported
    Are the data presentations, including visualizations, well-suited to represent the data? Somewhat appropriate and clear
    How clearly do the authors discuss, explain, and interpret their findings and potential next steps for the research? Very clearly
    Is the preprint likely to advance academic knowledge? Moderately likely
    Would it benefit from language editing? No
    Would you recommend this preprint to others? Yes, but it needs to be improved
    Is it ready for attention from an editor, publisher or broader audience? Yes, after minor changes

    Competing interests

    The author declares that they have no competing interests.

    Use of Artificial Intelligence (AI)

    The author declares that they did not use generative AI to come up with new ideas for their review.

  2. Version published to 10.64898/2026.05.03.26352313 on medRxiv