This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.
To evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Ph-positive lymphoblastic leukemia. Newly diagnosed Ph-positive patients will be given VP chemotherapy for induction treatment until the leukocyte count is less than 10×109/L. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a infusion of ThisCART19A. These patients will combination with Olverembatinib as maintenance therapy based on the hematologic complete remission of leukemia after 4 weeks of treatment. Patients could receive an additional infusion of ThisCART19A if they achieved initial benefit and subsequently minimal residual disease positive (defined as Flow-cytometric MRD≥0.1%) during maintenance treatment. Additionally, a subset of patients which achieved complete molecular remission over 6 month were eligible for a second planned infusion as a consolidation therapy . During the treatment, lumbar puncture combined with sheath injection will be performed to prevent central nervous system leukemia (CSNL). If CNSL occurs at the time of admission, patients should receive regular conventional lumbar puncture and sheath injection for treating CNSL. During the treatment, each subject will be evaluated regularly, including hematological response, FCM-MRD, cytogenetic response and molecular remission rate, as well as adverse events. EFS and OS will be followed up for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
ThisCART19A is a new type CAR-T therapy for patients with ph+ ALL.
Fludarabine is used for lymphodepletion.
Cyclophosphamide is used for lymphodepletion.
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
Number of Participants with Complete Molecular Remission
Will be estimated along with the 95% credible intervals. Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
Time frame: 4 weeks
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
Time frame: 2 years
Objective Response Rate (ORR)
Will be estimated along with the 95% credible intervals. ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) .
Time frame: 2 years
Duration of Complete Molecular Remission
Will be estimated along with the 95% credible intervals.
Time frame: From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 years.
Event-free survival (EFS)
The Kaplan-Meier method will be used to assess EFS probabilities.
Time frame: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities.
Time frame: From the first day of treatment to time of death from any cause, assessed up 2 years
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a third-generation TKI