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RECRUITING
NCT06507514
PHASE1

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

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

15 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2024-04-01

Completion Date

2030-04-01

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

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.

Locations (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China