Efficacy and safety of low-dose TBI combined MAC regimen for HSCT in high-risk AML patients with active disease

Efficacy and safety of low-dose TBI combined MAC regimen for HSCT in high-risk AML patients with active disease

Background The management of high-risk acute myeloid leukaemia (AML) remains challenging, highlighting the need for innovative conditioning strategies beyond current regimens.Methods In the present single-arm study, a FACT regimen comprised of low-dose total body irradiation (TBI) with fludarabine,...

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Main Authors: Can Chen, Yang Fan, Ying Xu, Yaping Xie, Kuang Chen, Xilian Huang, Daquan Gao, Junfeng Tan, Lirong Liu, Shenxian Qian, Pengfei Shi
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Annals of Medicine
Subjects:
Acute myeloid leukaemia
allogeneic hematopoietic stem cell transplantation
conditioning regimen
prognosis
Online Access:https://www.tandfonline.com/doi/10.1080/07853890.2024.2446692
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Summary:Background The management of high-risk acute myeloid leukaemia (AML) remains challenging, highlighting the need for innovative conditioning strategies beyond current regimens.Methods In the present single-arm study, a FACT regimen comprised of low-dose total body irradiation (TBI) with fludarabine, cytarabine and cyclophosphamide was employed to treat cytogenetically high-risk AML patients exhibiting pre-transplant active disease. This clinical trial is registered in the Chinese Clinical Trial Registry with the registration number ChiCTR2000035111.Results In this study, 21 high-risk AML patients with pre-transplant disease statuses including primary induction failure, relapse and measurable residual disease positivity, were enrolled to undergo FACT conditioning. The FACT group demonstrated a 1-year non-relapse mortality (NRM) rate of 9.5%, indicating a similar level of safety and tolerability among the conditioning regimens. The estimated cumulative incidence of grade 2–4 acute graft-versus-host disease (GVHD) at one year was 30.7%. Additionally, the cumulative incidence of chronic GVHD was 36.0% at one year and increased to 43.0% at two years.Conclusions The FACT regimen is an effective myeloablative conditioning (MAC) strategy for high-risk AML patients, potentially reducing relapse risk without increasing NRM, warranting further research.
ISSN:0785-3890
1365-2060

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