This is a prospective, multicenter, randomized controlled trial designed to evaluate whether short-term blinatumomab intensification before allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival outcomes in adults with high-risk BCR::ABL1-negative B-cell acute lymphoblastic leukemia (B-ALL) who have achieved measurable residual disease (MRD) negativity. Blinatumomab, a CD19/CD3 bispecific T-cell engager, has shown promising efficacy in eradicating MRD and prolonging survival in B-ALL patients. In this study, eligible participants will be randomly assigned to receive either short-term blinatumomab consolidation prior to allo-HSCT or proceed directly to allo-HSCT. The primary endpoint is relapse-free survival (RFS). This study aims to optimize treatment strategies and improve long-term outcomes for patients with high-risk BCR::ABL1-negative B-ALL.
Age > 35 years
Peripheral WBC count > 30 × 10⁹/L
Hypodiploidy (<44 chromosomes)
TP53 mutation
Prior exposure to blinatumomab, chimeric antigen receptor (CAR) T-cell therapy, or anti-CD22 immunotoxins.
Clinically significant cardiovascular disease, including uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, NYHA class III or IV heart disease, or myocardial infarction within 3 months prior to screening.
Other severe comorbidities that may limit participation in the trial (e.g., severe infection, renal failure).
Known HIV infection or uncontrolled severe viral hepatitis.
Parallel
Blinatumomab
DrugBlinatumomab is administered starting approximately one month before allogeneic hematopoietic stem cell transplantation (allo-HSCT). For participants weighing ≥45 kg: 9 μg/day is administered on Days 1-3, followed by 28 μg/day on Days 4-14. For participants weighing \<45 kg: 5 μg/m²/day (based on body surface area) is administered on Days 1-3, followed by 15 μg/m²/day on Days 4-14. The total dose must not exceed the dosage used for participants ≥45 kg.
Consolidation Chemotherapy or Direct Allogeneic HSCT
Other interventionParticipants in the Non-BiTE group will either proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT) or receive one additional cycle of consolidation chemotherapy prior to
2-year Relapse-Free Survival (RFS)
Relapse-free survival is defined as the time from transplantation to either disease relapse or death from any cause, whichever occurs first. Patients who are alive and relapse-free at 2 years will be considered as having achieved 2-year RFS.
Cumulative Incidence of Relapse (CIR)
Defined as the cumulative incidence of hematologic relapse, accounting for competing risks such as non-relapse mortality.
Non-Relapse Mortality (NRM)
Death from any cause without prior hematologic relapse.
Incidence of Hematologic and Non-Hematologic Adverse Events
Safety evaluation based on CTCAE v5.0 criteria, including treatment-related cytopenias, infections, neurotoxicity, and other adverse events.
Measurable Residual Disease (MRD) Status
MRD status assessed using multi-parameter flow cytometry or PCR prior to HSCT. Evaluated as MRD-negative or MRD-positive.
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First Affiliated Hospital of Zhejiang University
Lead sponsor
Ruijin Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
