Actively Recruiting
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
77
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed/refractory (R/R) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.
CONDITIONS
Official Title
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with de novo and primary Philadelphia chromosome/BCR-ABL1 negative acute lymphoblastic leukemia confirmed by bone marrow and molecular tests according to WHO classification
- Male or female aged 18 years or older
- Leukemia cells must express CD19
- Expected survival time greater than 3 months
- Adequate organ function including total bilirubin ≤ 1.5 x upper limit of normal; ALT and AST ≤ 2.5 x upper limit of normal (or ≤ 5 x if liver involved); creatinine ≤ 1.5 x upper limit of normal; amylase and lipase ≤ 1.5 x upper limit of normal; alkaline phosphatase ≤ 2.5 x upper limit of normal unless tumor-related; normal potassium, magnesium, phosphorus levels; cardiac ejection fraction ≥ 45%
- Provided written informed consent before any screening procedures
You will not qualify if you...
- Diagnosis of Burkitt lymphoma/leukemia
- Diagnosis of acute leukemia of ambiguous lineage
- Active central nervous system or extramedullary involvement with leukemia
- Female patients who are pregnant or breastfeeding
- Uncontrolled active serious infections that may interfere with treatment completion
- Known HIV positive status
- Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal), sinus block, or history of chronic bradycardia with high-degree atrioventricular conduction block unless a permanent pacemaker is implanted
- Serious psychiatric illness that may interfere with treatment completion
- Other conditions deemed inappropriate for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020
Actively Recruiting
Research Team
J
Jianxiang Wang, Dr
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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