NCT06507514

Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Safety and Efficacy of Blinatumomab and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main method potentially curing adult B-ALL, but the high treatment-related mortality (NRM) affects overall survival (OS). Autologous stem cell transplantation (auto-HSCT) can significantly reduce NRM but has a higher relapse rate. Studies have confirmed that achieving MRD negativity before Auto-HSCT can effectively reduce post-transplant relapse, achieving similar efficacy to allo-HSCT. The efficacy of blinatumomab in clearing MRD has been confirmed. Therefore, using blinatumomab combined with Auto-HSCT for B-ALL patients seems to make it possible to achieve benefits in leukemia free survival（LFS） and OS. The investigators first conducted blinatumomab and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.

Detailed description

Enrolled patients received induction chemotherapy with the IVP regimen and two cycles of consolidation chemotherapy: high-dose cytarabine (Ara-c) + pegaspargase (± Tyrosine kinase inhibitors ,TKI) and methotrexate (MTX) + pegaspargase (± TKI). Sequential treatment with blinatumomab was then administered. After the first treatment with blinatumomab, autologous stem cell mobilization and collection were performed. Following successful stem cell collection, autologous stem cell transplantation was conducted. Starting from the third month after autologous stem cell transplantation, the second maintenance treatment with blinatumomab was administered, with one cycle every three months, for a total of four cycles. Long-term follow-up monitoring was then conducted. The follow-up period for this study was two years, and data on two-year LFS, OS, and NRM rates were collected.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	blinatumomab and auto-HSCT "sandwich " strategy	The patients received sequential infusion of blinatumomab after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed 6-8 weeks after infusion. Following successful stem cell collection, autologous stem cell transplantation was conducted. Starting from the third month after autologous stem cell transplantation, the second maintenance treatment with brentuximab vedotin was administered, with one cycle every three months, for a total of four cycles. Patients were followed up and minimal residual diseases (MRD) was monitored by flow cytometry and second-generation gene sequencing of IgH rearrangement.

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-04-01
• Completion: 2030-04-01
• First posted: 2024-07-18
• Last updated: 2025-11-21

Locations

1 site across 1 country: China