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

November 18, 2025 updated by: Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.
  • positive expression of CD19 in peripheral blood or bone marrow primary cells detected by flow cytometry.
  • ardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation > 91% without oxygenation.
  • subjects aged 15-65 years (including 15 and 65 years), regardless of gender.
  • T-cell amplification test pass.
  • expected survival > 3 months.

Exclusion Criteria:

  • patients with recurrence of only isolated extramedullary lesions. combination of other malignant tumors.
  • previously treated with anti-CD19 therapies.
  • immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent.
  • uncontrolled active infections.
  • HIV infection.
  • active hepatitis B or hepatitis C infection.
  • history of severe tachyphylaxis to aminoglycoside antibiotics.
  • history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blinatumomab and Auto-HSCT Sandwich Strateg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival（OS）
Time Frame: 4 years
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
4 years
leukemia free survival（LFS）
Time Frame: 4 years
It is measured from the date of achievement of a remission until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 4 years
Adverse events are evaluated with CTCAE V5.0 from the date of entry into this trial.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZBALL02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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