RecruitingPhase 1NCT06507514

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

4 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 15 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment strategy for B-cell acute lymphoblastic leukemia (B-ALL) — a type of blood cancer — that combines a targeted drug called blinatumomab with a stem cell transplant using the patient's own cells (auto-HSCT). The goal is to find a better consolidation treatment for patients who cannot or do not want a stem cell transplant from a donor. **You may be eligible if...** - You have been diagnosed with B-ALL and either cannot find a matching donor or have chosen not to have a donor transplant - Your cancer cells test positive for a protein called CD19 - You are between 15 and 65 years old - Your heart, liver, kidneys, and lungs are working adequately - Your immune T-cells can be successfully grown in the lab **You may NOT be eligible if...** - Your cancer has only returned in areas outside the bone marrow (extramedullary only) - You have another active cancer - You have previously received treatments targeting CD19 - You have an uncontrolled infection, HIV, or active hepatitis B or C - You have a serious neurological condition such as epilepsy, stroke, dementia, or Parkinson's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTblinatumomab 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.