Relapse is the major cause of treatment failure in Philadelphia chromosome‐positive (Ph+) acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (allo‐HSCT). This study aimed to evaluate the effect of a prophylactic tyrosine kinase inhibitor (TKI) strategy on relapse in this population. Patients were assigned to prophylactic or control groups based on measurable residual disease (MRD) pre‐transplantation. The primary endpoint was the cumulative incidence of relapse. A total of 110 patients with Ph+ ALL undergoing allo‐HSCT were enrolled in this prospective study. Thirty‐eight patients with positive MRD pre‐transplantation were included in the prophylactic group, and 72 with negative MRD pre‐transplantation were included in the control group. The 4‐year cumulative incidence of relapse was 25.3% (95% CI: 12.1%–41.0%) and 20.3% (11.6%–30.7%; HR = 1.272, 95% CI: 0.551–2.940, p = .549), and non‐relapse mortality was 10.5% (3.3%–22.7%) and 9.7% (4.2%–17.9%; HR = 1.094, 95% CI: 0.320–3.738, p = .928) in the prophylactic and control groups. The 4‐year overall survival was 71.8% (53.2%–84.1%) and 84.1% (72.9%–90.9%; HR = 1.746, 95% CI: 0.741–4.112, p = .196), and leukemia‐free survival was 64.1% (45.8%–77.7%) and 70.0% (57.6%–79.4%; HR = 1.212, 95% CI: 0.607–2.421, p = .585) in the prophylactic and control groups. Our results suggest that prophylactic TKI post‐HSCT in patients with positive MRD pre‐transplantation can produce outcomes comparable to negative MRD pre‐transplantation without TKI post‐HSCT.

中文翻译：

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针对接受同种异体造血干细胞移植的 Ph+ 急性淋巴细胞白血病，基于移植前可测量残留病灶的预防性酪氨酸激酶抑制剂策略：一项前瞻性多中心队列研究


复发是费城染色体阳性 （Ph+） 急性淋巴细胞白血病 （ALL） 接受同种异体造血干细胞移植 （allo-HSCT） 治疗失败的主要原因。本研究旨在评估预防性酪氨酸激酶抑制剂 （TKI） 策略对该人群复发的影响。根据移植前可测量的残留病 （MRD） 将患者分配到预防组或对照组。主要终点是累积复发率。共有 110 例接受同种异体造血干细胞移植的 Ph+ ALL 患者被纳入这项前瞻性研究。38 例移植前 MRD 阳性患者纳入预防组，72 例移植前 MRD 阴性患者纳入对照组。4 年累积复发率为 25.3% （95% CI： 12.1%–41.0%） 和 20.3% （11.6%–30.7%;HR = 1.272,95% CI：0.551–2.940，p = .549），非复发死亡率为 10.5% （3.3%–22.7%） 和 9.7% （4.2%–17.9%;HR = 1.094,95% CI：0.320–3.738，p = .928）。4 年总生存率分别为 71.8% （53.2%–84.1%） 和 84.1% （72.9%–90.9%;HR = 1.746,95% CI：0.741–4.112，p = .196），无白血病生存率为 64.1% （45.8%–77.7%） 和 70.0% （57.6%–79.4%;HR = 1.212,95% CI：0.607–2.421，p = .585）。我们的结果表明，移植前 MRD 阳性患者的 HSCT 后预防性 TKI 可以产生与 HSCT 后无 TKI 的移植前阴性 MRD 相当的结果。