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Efficacy and Safety of Molecular Targeted Therapy Combined With Chemotherapy and Sequential CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Positive B-cell Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
82
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for adults newly diagnosed with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia Ph ALL. This approach combines targeted molecular therapy with chemotherapy followed by CAR-T cell therapy as a consolidation treatment. The goal is to improve survival and quality of life by increasing remission depth and reducing chemotherapy cycles and related side effects. The treatment involves using overembatinib a tyrosine kinase inhibitor, venetoclax a BCL2 inhibitor, and reduced-intensity chemotherapy to achieve complete remission. After remission, patients receive a single infusion of second-generation murine-derived CD19 CAR-T cells with a co-stimulation domain of 4-1BB at a dose of 1106 CAR cells per kilogram. This sequence aims to shorten hospital stays and lower toxicity. The study includes only one treatment group receiving this combination and follows patients for up to 5 years. Participants will undergo regular assessments including disease-free survival DFS over 2 years, overall survival OS, event-free survival EFS, molecular remission rates, minimal residual disease remission, relapse rates, and treatment-related toxicities. Quality of life will also be monitored. Safety and efficacy outcomes are tracked through blood tests, imaging, and molecular analyses. The study started in June 2024 and is expected to continue through mid-2028, with ongoing follow-up visits throughout this period.
CONDITIONS
Brief Title
Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia confirmed by t(9;22), BCR-ABL positivity, or FISH
- CD19 expression on leukemia blasts
- Expected survival time greater than 3 months
- Adequate organ function including normal bilirubin, liver enzymes, creatinine, amylase, lipase, alkaline phosphatase, electrolytes, and cardiac ejection fraction of at least 45%
- Provided written informed consent prior to screening
You will not qualify if you...
- Lymphoid blast crisis of chronic myelocytic leukemia
- Previous or ongoing systemic anti-ALL therapy except appropriate pre-treatment
- History of myocardial infarction within 12 months or significant cardiac disease such as unstable angina, heart failure, uncontrolled hypertension or arrhythmia
- Uncontrolled active serious infections
- Known HIV infection
- History of acute or chronic pancreatitis within 1 year
- Uncontrolled hypertriglyceridemia (triglycerides over 450 mg/dL)
- Another malignancy diagnosed or treated within 5 years or residual disease from prior malignancy (except fully excised non-melanoma skin cancer or carcinoma in situ)
- Pregnant or breastfeeding women
- Active central nervous system or extramedullary involvement with ALL
- Poorly controlled diabetes with HbA1c over 7.5%
- Serious psychiatric illness interfering with treatment
- Other conditions deemed inappropriate by investigators
Research Team
J
Jianxiang Wang, Dr
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