ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Intravenous infusion
Orally by mouth
subcutaneous injection or Intravenous infusion
subcutaneous injection
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion or orally
subcutaneous injection
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITING1-year EFS
1-year event free survival rate
Time frame: 1 year
CR/CRi
Complete remission/complete remission with incomplete count recovery
Time frame: At the end of Cycle 1 (up to 42 days)
OS
Overall survival
Time frame: through study completion, up to 3 years
MRD
Percentage of participants who converted to MRD \< 10\^-3 after the first cycle of treatment.
Time frame: At the end of Cycle 1 (up to 42 days)
Safety of induction therapy
Adverse events
Time frame: At the end of Cycle 1 (up to 42 days)
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