In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of a novel third-generation TKI Olverembatinib. The main purpose of the study is to evaluate the efficacy and safety of Olverembatinib in Ph+ ALL patients.
Eligible participants will receive an 28-day induction regimen of Olverembatinib (40mg, QOD) combined with VP-chemotherapy, followed by 4 cycles of Hyper-CVAD A/B treatment (each lasting 28 days). If complete molecular response (CMR) is achieved at the 3rd month, participants will receive another three cycles of Hyper-CVAD A/B treatment. Maintenance therapy would be given for at least 1 year with monthly courses of vincristine, prednisone and Olverembatinib. If participants fail to achieve CMR at the 3rd month, or patients with an available matched donor had the option to proceed to allogeneic stem cell transplantation (allo-HSCT) at the discretion of the treating physician. Olverembatinib would be administered at the time of hematopoietic reconstruction for at least 1 year. Intrathecal injection would be performed on day 15 of induction therapy and before each course of consolidation therapy to prevent central nervous system leukemia (CNSL). It is expected that about 55 patients will take part in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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.
Time frame: From Induction through the end of one cycle of Hyper-CVAD A and B (approximately 3 months) (Cycle length is equal to [=] 28 days) ]
Percentage of Participants with CR and Incomplete Complete Remission (CRi)
Will be estimated along with the 95% credible intervals.
Time frame: At the end of consolidation therapy (approximately 9 months) and one year after allo-HSCT
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 to 4 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 to 4 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 to 4 years.
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: Up to approximately 2 to 4 years
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