This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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
Overall 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)
Complete Remission Rate (CRR)
The complete remission 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: 1 year
Relapse-Free Survival (RFS)
It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause.
Time frame: 1 year
Adverse events in hematological system
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Time frame: 1 month
Adverse events in other organs or systems
Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.
Time frame: 1 month
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