biostudies-literatureWan YScience and Technology Commission of Shanghai MunicipalityChinese Academy of Medical SciencesNational Natural Science Foundation of ChinaNational Cancer InstituteAmerican Lebanese Syrian Associated CharitiesNCI NIH HHSInnovationsfondenNational Institutes of HealthChildren's Cancer Foundation587-596https://www.ebi.ac.uk/biostudies/studies/S-EPMC9649883biostudies-literatureUnknown199(4)The effect of prolonged pulse therapy with vincristine and dexamethasone (VD) during maintenance therapy on the outcome of paediatric patients with TCF3-PBX1 positive acute lymphoblastic leukaemia (ALL) remains uncertain. We conducted non-inferiority analysis of 263 newly diagnosed TCF3-PBX1 positive ALL children who were stratified and randomly assigned (1:1) to receive seven additional VD pulses (the control group) or not (the experimental group) in the CCCG-ALL-2015 clinical trial from January 2015 to December 2019 (ChiCTR-IPR-14005706). There was no significant difference in baseline characteristics between the two groups. With a median follow-up of 4.2 years, the 5-year event-free survival (EFS) and 5-year overall survival (OS) in the control group were 90.1% (95% confidence interval British journal of haematologyExtended vincristine and dexamethasone pulse therapy may not be necessary for children with TCF3-PBX1 positive acute lymphoblastic leukaemia.PMC9649883P30 CA021765(81670136) (JCa)(21Y31900302) (XWZ)(82141125) (XWZ)(81870131) (XFZ)Ju XHu SPui CHZhang HJiang HCai JGao JWan YZhang LYu JWang JLiang CSun LWang NTang JLi CKZhai XShen SWu XLi HYang JJin RYang MFang YTian XLeung AWKZhu XHu QfalseExtended vincristine and dexamethasone pulse therapy may not be necessary for children with TCF3-PBX1 positive acute lymphoblastic leukaemia.The effect of prolonged pulse therapy with vincristine and dexamethasone (VD) during maintenance therapy on the outcome of paediatric patients with TCF3-PBX1 positive acute lymphoblastic leukaemia (ALL) remains uncertain. We conducted non-inferiority analysis of 263 newly diagnosed TCF3-PBX1 positive ALL children who were stratified and randomly assigned (1:1) to receive seven additional VD pulses (the control group) or not (the experimental group) in the CCCG-ALL-2015 clinical trial from January 2015 to December 2019 (ChiCTR-IPR-14005706). There was no significant difference in baseline characteristics between the two groups. With a median follow-up of 4.2 years, the 5-year event-free survival (EFS) and 5-year overall survival (OS) in the control group were 90.1% (95% confidence interval 2022-01-01T00:00:00Z2022 Nov2025-04-04T22:50:42.999Z2025-04-04T22:50:42.999ZS-EPMC96498833611400910.1111/bjh.18437