The Efficacy of AntiCD19 CAR-T Combined With BTKi in Newly Diagnosed High-risk CLL Patients and Its Safety as Limited-term Treatment

What this Trial Is About

Researchers are evaluating a new treatment approach for patients newly diagnosed with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study aims to improve long-term outcomes by combining AntiCD19 CAR-T cell therapy with Bruton's tyrosine kinase inhibitors (BTKi). This approach is being explored because current first-line treatments for high-risk patients lack sufficient research, and this combination may increase the rate of undetectable minimal residual disease (uMRD) and reduce the need for long-term medication. The treatment involves collecting blood samples to assess the patient's suitability for CAR-T cell production. If suitable, patients receive an infusion of AntiCD19 CAR-T cells combined with BTKi. After treatment, patients undergo regular assessments every three months for one year to measure minimal residual disease in blood and bone marrow and monitor CAR-T cell expansion. Following this, a two-year telephone follow-up and questionnaires will evaluate long-term health, including tumor recurrence and quality of life. During the study, participants will have their medical history reviewed, and undergo imaging, physical exams, blood tests, and bone marrow evaluations to assess disease status and treatment effects. Safety and toxicity are monitored throughout. The primary outcome is the negative rate of minimal residual disease within one year. Secondary outcomes include remission response rates and progression-free survival. The total participation includes one year of active assessment followed by two years of follow-up, helping researchers understand the treatment's long-term impact.

Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL