Actively Recruiting
Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-05-04
101
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy. The primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity. The trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .
CONDITIONS
Official Title
Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 15 and 65 years
- Newly diagnosed Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia with CD19 expression of 20% or more
- No prior induction therapy for leukemia except for hydroxyurea or corticosteroids used for 5 days or less
- ECOG performance status score between 0 and 3
- Liver function with total bilirubin no more than 3 times the upper limit of normal and ALT and AST no more than 3 times the upper limit of normal, excluding leukemic infiltration
- Kidney function with creatinine clearance rate of at least 30 mL/min
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Philadelphia chromosome-positive (Ph+, BCR-ABL1+) acute lymphoblastic leukemia
- T-cell acute lymphoblastic leukemia
- Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, or disease with extramedullary invasion
- Mixed phenotype acute leukemia
- Central nervous system leukemia
- HIV infection
- Positive hepatitis B virus DNA or hepatitis C virus RNA
- New York Heart Association functional class II or higher, or other conditions considered unsuitable by the investigator
- Pregnancy or lactation
- Refusal to enroll in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
J
Jing Lu Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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