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NCT06507514RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
4 (estimated)
First submitted
12 Jul 2024
Start date
1 Apr 2024
Primary completion date
1 Apr 2028
Lead sponsor
The First Affiliated Hospital of Soochow University
NCT number
NCT06507514

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 4
  • From 1 Apr 2024 to the primary completion date, 1 Apr 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previously treated with anti-CD19 therapies.
  • immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent.

Other illness

  • patients with recurrence of only isolated extramedullary lesions. combination of other malignant tumors.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 15 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affliated Hospital of Soochow University
Coordinator of this site? Confirm its status		SuzhouChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.