Actively Recruiting
Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-06-04
114
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized controlled trial designed to evaluate whether short-term blinatumomab intensification before allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival outcomes in adults with high-risk BCR::ABL1-negative B-cell acute lymphoblastic leukemia (B-ALL) who have achieved measurable residual disease (MRD) negativity. Blinatumomab, a CD19/CD3 bispecific T-cell engager, has shown promising efficacy in eradicating MRD and prolonging survival in B-ALL patients. In this study, eligible participants will be randomly assigned to receive either short-term blinatumomab consolidation prior to allo-HSCT or proceed directly to allo-HSCT. The primary endpoint is relapse-free survival (RFS). This study aims to optimize treatment strategies and improve long-term outcomes for patients with high-risk BCR::ABL1-negative B-ALL.
CONDITIONS
Official Title
Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) according to the 2022 WHO classification
- Age between 18 and 65 years
- High-risk B-ALL based on clinical or cytogenetic/molecular features including age > 35 years, high peripheral WBC count, or specific genetic rearrangements and mutations
- CD19-positive by immunophenotyping
- BCR::ABL1-negative
- Achieved complete remission after induction therapy
- Measurable residual disease (MRD)-negative by flow cytometry
- Availability of a matched sibling donor, haploidentical related donor, or matched/unmatched unrelated donor
- ECOG performance status score of 0-2
- Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault formula)
- AST and ALT ≤ 3 × upper limit of normal; total bilirubin ≤ 2 × upper limit of normal
- Left ventricular ejection fraction ≥ 50% by echocardiography
- Expected survival greater than 8 weeks
- Signed written informed consent with ability to understand and comply with the study protocol
You will not qualify if you...
- Prior exposure to blinatumomab, chimeric antigen receptor (CAR) T-cell therapy, or anti-CD22 immunotoxins
- Clinically significant cardiovascular disease including uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, NYHA class III or IV heart disease, or myocardial infarction within 3 months prior to screening
- Other severe comorbidities that may limit participation such as severe infection or renal failure
- Known HIV infection or uncontrolled severe viral hepatitis
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
Hengwei Wu Attending, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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