This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy.
Treatment Protocol
1. Low-intensity chemotherapy (VIP regimen)
* V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8. * I (Idarubicin): 8 mg/m²/day on days 1 and 8. * P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14. 2. Sequential induction therapy:
* Blinatumomab administered for 2 weeks following the VIP regimen. 3. Consolidation therapy for morphological complete remission (CR)
* Patients achieving CR receive two cycles of consolidation chemotherapy: * Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone). * Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate). 4. Allogeneic hematopoietic stem cell transplantation (allo-HSCT):
* Patients with multiparameter flow cytometry-confirmed minimal residual disease (MRD)-negative status proceed to allo-HSCT.
Patients achieving morphological complete remission (CR) will undergo two cycles of consolidation chemotherapy. Those with minimal residual disease (MRD)-negative status confirmed by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) will proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 18-month relapse-free survival (RFS) rate, the secondary endpoints were composite response rate (CRc: CR + CR with incomplete hematologic recovery \[CRi\]), MRD-negative rate (assessed by MFC/NGS),18-month overall survival (OS) post-transplant, non-relapse mortality (NRM), cumulative incidence of acute/chronic graft-versus-host disease (GVHD), cumulative relapse rate and 18-month GVHD-free/relapse-free survival (GRFS) post-transplant.
Bone marrow morphology
Cytochemistry
Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)
Chromosomal analysis
Non-de novo patients(i.e., relapsed/refractory disease).
BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).
Active bacterial, viral, or fungal infections requiring treatment.
Hepatitis B: HBsAg-positive or HBcAb-positive with detectable HBV DNA in peripheral blood.
Single group
Blinatumomab plus Reduced-dose Chemotherapy
DrugNewly diagnosed Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (Ph-negative B-ALL) patients aged 18-60 years were enrolled. Treatment Protocol 1. Low-intensity chemotherapy (VIP regimen) * V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8. * I (Idarubicin): 8 mg/m²/day on days 1 and 8. * P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14. 2. Sequential induction therapy: * Blinatumomab administered for 2 weeks following the VIP regimen. 3. Consolidation therapy for morphological complete remission (CR) * Patients achieving CR receive two cycles of consolidation chemotherapy: * Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone). * Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate). 4. Allogeneic hematopoietic stem cell transplantation (allo-HSCT): * Patients with multiparameter flow cytometry-confirmed minimal res
RFS
18-month relapse-free survival (RFS) rate post-allo-HSCT in newly diagnosed Ph- B-ALL patients treated with low-intensity chemotherapy followed by short-course blinatumomab induction.
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Xianmin Song, MD
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor institution
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