About this trial
ETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: >14 to 65 years (inclusive).
Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose <0.5g, and leukapheresis).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Expected survival >6 months.
Disqualifiers
Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.
Presence of central nervous system (CNS) leukemia.
Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.
Trial design
Single group
Treatments tested in this trial
VEN (Venetoclax)
DrugOrally
Azacitidine (AZA)
DrugSubcutaneous injection
Chidamide
DrugOrally
vindesine
Drugintravenous infusion
Dexamethasone
Drugintravenous infusion or orally
Treatment groups
Trial outcomes
Primary outcomes
Composite Complete Remission Rate(CRc) after induction therapy
Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)
Secondary outcomes
Overall survival(OS)
Time from the date of enrollment to death from any cause or the last follow-up
Relapse-Free Survival(RFS)
The duration from the date of the first complete remisson to the occurrence of relapse, death from any cause, or the last follow-up.
duration of remission (DOR)
Time between the first remission and relapse
AE
Adverse events during the chemotherapy treatment.
Sponsors and contacts
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