The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
NCT Number: NCT05149378
This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.
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Notify Me15 year–70 year
All sexes
Interventional
Phase 2
Suzhou, Jiangsu, 215006, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
Exclusion criteria
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 .
Time frame: At the end of Cycle 1 (each cycle is 21 days)
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)
The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
Time frame: 1 year
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
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 month
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Time frame: 1 month
Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.
The First Affiliated Hospital of Soochow University
Other
Venetoclax Based Regimen for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
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