To explore the efficacy and safety ofblinatumomab± TKI in B-ALL patients aged ≥ 14 years with NGS-MRD relapse (sensitivity: 10-6) after auto/allo HSCT, and to observe the disease-free survival (DFS), recurrence rate and toxicity after transplantation.
The cytogenetic prognosis of adult acute B lymphoblastic leukemia in accordance with NCCN 2023 at initial diagnosis was divided into poor prognosis group;
Patients with relapsed and refractory ALL and MRD-positive ALL before transplantation,
Refractory ALL is one of the following conditions. A）Failure to achieve CR/CRi at the end of induction therapy (generally referred to as 4-week regimen or Hyper-CVAD regimen).
Relapsed ALL is defined as the appearance of blasts in the peripheral blood or bone marrow (> 5%), or the development of extramedullary disease in patients who have achieved CR.
None
Single group
Blinatumomab
Drug* Ph-negative B-ALL: bephedolumab (≥ 45 kg: 9 mcg/d D1-2, 28 mcg/d D3-14 or 28 mcg/d D1-14; \< 45 kg: 5 mg/m2/d D1-2, 15 mg/m2/d D3-14) in 28-day cycles for 3 cycles. * Ph-positive B-ALL: treatment with bephytoin + TKIs, bephytoin (≥ 45 kg: 9 mcg/d D1-2, 28 mcg/d D3-14 or 28 mcg/d D1-14; \< 45 kg: 5 mg/m2/d D1-2, 15 mg/m2/d D3-14) in 28-day cycles for 3 cycles.
disease-free survival (DFS)
disease-free survival (DFS)
recurrence rate
recurrence rate
NGS-MRD response rate
Bone marrow was collected from patients at 3 and 6 months after transplantation and at 15 days after treatment with blinatumomab, and immunoglobulin rearranged IGH-VDJ sequences were monitored using high-throughput sequencing (NGS) to identify significant clonal sequences to regularly determine changes in MRD levels before and after treatment.
overall survival (OS)
overall survival (OS)
incidence of acute and chronic GVHD
The frequency and severity of acute GVHD of the intestine, skin, and liver were observed until 100 days after transplantation, and all episodes of GVHD were graded using the clinical grading criteria for acute GVHD. The changes of skin, liver function, eyes, and oral cavity of patients after 100 days after transplantation were observed to assess the incidence of localized and extensive chronic GVHD.
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