This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.
The primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.
Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria.
CD22-positive expression on tumor cells (CD22 ≥20%).
Expected survival ≥3 months.
Sexually active men and women of childbearing potential must agree to use effective contraception.
Burkitt lymphoma/leukemia.
Acute leukemia of ambiguous lineage.
Pregnant women.
Severe, uncontrolled active infections.
Sequential
Inotuzumab Ozogamicin (IO)
DrugAnti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.
Venetoclax
DrugBCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.
Blinatumomab
DrugCD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.
CD19-directed chimeric antigen receptor (CAR-T) T cells
Biological/VaccineAutologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.
Vincristine
DrugA vinca alkaloid that inhibits microtubule formation by binding to tubulin, resulting in mitotic arrest and inhibition of proliferation of rapidly dividing leukemic cells.
Cyclophosphamide
DrugAn alkylating agent that forms DNA cross-links, leading to inhibition of DNA replication and transcription and subsequent apoptosis of rapidly proliferating hematopoietic cells.
Dexamethasone
DrugA synthetic glucocorticoid that induces lymphoid cell apoptosis and exerts anti-inflammatory and immunosuppressive effects, contributing to reduction of leukemic burden.
Methotrexate
DrugA folate antimetabolite that inhibits dihydrofolate reductase, resulting in impaired DNA synthesis and cell replication, particularly in rapidly dividing lymphoid cells.
Cytarabine (Ara-C)
DrugA pyrimidine nucleoside analog that inhibits DNA polymerase, leading to termination of DNA chain elongation and inhibition of leukemic cell proliferation.
Prednisone
DrugA glucocorticoid that induces apoptosis in lymphoid cells and provides anti-inflammatory and immunosuppressive effects as part of multi-agent leukemia therapy.
Mercaptopurine 50 mg
DrugA purine analog antimetabolite that interferes with purine nucleotide synthesis and incorporates into DNA and RNA, inhibiting nucleic acid synthesis and cell proliferation.
Flow Cytometric MRD-Negative Complete Remission Rate
Proportion of patients achieving complete remission (CR) with negative measurable residual disease (MRD) assessed by multiparameter flow cytometry after completion of induction therapy.
Next-Generation Sequencing (NGS)-MRD Negative Remission Rate
Proportion of patients achieving MRD-negative remission assessed by immune repertoire sequencing.
Best MRD Clearance Rate
Proportion of patients achieving the deepest MRD response during the first 3 months of treatment as assessed by flow cytometry, quantitative PCR, or immune repertoire sequencing.
Overall Survival (OS)
Time from study enrollment to death from any cause.
Disease-Free Survival (DFS)
Time from achievement of complete remission to relapse or death from any cause.
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