Actively Recruiting
Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-21
4
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with B-cell Acute Lymphoblastic Leukemia and either has no suitable allogeneic HSCT donor or refuses allogeneic HSCT
- Positive CD19 expression detected in peripheral blood or bone marrow cells by flow cytometry
- Left ventricular ejection fraction of at least 50% by cardiac ultrasound
- Creatinine level of 1.6 mg/dl or lower
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) levels no more than three times the normal range
- Total bilirubin level 2.0 mg/dl or lower
- Pulmonary function with grade 1 or less dyspnea and oxygen saturation above 91% without oxygen support
- Aged between 15 and 65 years inclusive
- Passed T-cell amplification test
- Expected survival longer than 3 months
You will not qualify if you...
- Recurrence involving only isolated extramedullary lesions or presence of other malignant tumors
- Previous treatment with anti-CD19 therapies
- Use of immunosuppressants within 2 weeks before consent or planned use after consent
- Uncontrolled active infections
- HIV infection
- Active hepatitis B or hepatitis C infection
- History of severe reaction to aminoglycoside antibiotics
- History or presence of significant central nervous system disorders such as epilepsy, seizures, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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