This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.
1) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures.
>CR1 status
Pre-transplant MRD+ status
Ph-like subtype
1) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).
Liver: ALT or AST > 2.5 × ULN; Total bilirubin > 2 × ULN
Kidney: Serum creatinine > ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).
Single group
Blinatumomab Injection
Drugblinatumomab 9ug d1-7, 28ug d8-14
Donor Lymphocyte Infusion (DLI)
Other interventionCD3+cell 1×10\^5/kg
1 year progression-free-survival
the percentage of patients who remain alive and whose disease has not gotten relapse one full year after they started treatment.
1 year aGVHD rate
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) The cumulative incidences of aGvHD was defined as the number and the ratio of the participants with aGVHD.
1 year cGVHD rate
Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) cGvHD was diagnosed and graded according to the 2014 National Institutes of Health (NIH) consensus criteria: mild, moderate or severe respectively.
Nonrelapse mortality (NRM)
Defined as the proportion of subjects who died due to causes other than malignancy relapse
Overall survival (OS)
Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause
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Liping Dou
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
