The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.
This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate (ORR)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Overall survial (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time frame: 2 years
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death.
Time frame: 2 years
Number of adverse events
Adverse events are evaluated with CTCAE V5.0.
Time frame: 2 years
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