NCT06930105

Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL

Impact of Low-Intensity Chemotherapy Combined With Short-Course Blinatumomab on Allo-HSCT in Adults With Newly Diagnosed Ph-B-ALL: A Single-Arm, Prospective, Multicenter, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Xianmin Song, MD · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Lymphoid Leukemia (ALL)

Interventions

Type	Name	Description
DRUG	Blinatumomab plus Reduced-dose Chemotherapy	Newly 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

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-11-01
• Completion: 2028-05-01
• First posted: 2025-04-16
• Last updated: 2025-08-06