The goal of this clinical trial is to evaluate the efficacy and safety of venetoclax combined with azacitidine in treating newly diagnosed early T-cell precursor (ETP)-like acute lymphoblastic leukemia (ALL), T-ALL with myeloid mutations, or T/myeloid mixed-phenotype acute leukemia (T/My-MPAL).
Participant population: Patients aged ≥14 years diagnosed with ETP-like leukemia, T-ALL with myeloid mutations, or T/My-MPAL, regardless of sex/gender.
The main question it aims to answer: Does venetoclax plus azacitidine achieve a significantly higher overall response rate (ORR: CR + CRi) compared to historical controls (54% vs. 90%) after two induction cycles?
Comparison group: Researchers will compare ORR outcomes to historical data from conventional chemotherapy regimens to assess treatment superiority.
Participants will:
* Receive two 28-day cycles of venetoclax (oral, 100 mg D1, 200 mg D2, 400 mg D3-28) and azacitidine (75 mg/m²/day SC, D1-7). * Undergo serial bone marrow biopsies, blood tests, and imaging (e.g., PET-CT) for response assessment. * Follow dose adjustment protocols for toxicity management (e.g., neutropenia, thrombocytopenia).
No gender restrictions
Age ≥ 14 years
Newly diagnosed patients without prior induction therapy Limited prior therapy allowed: hydroxyurea, dexamethasone, or low-dose cytarabine/venetoclax (cumulative dose <0.5g), and leukocytapheresis
Expected survival time ≥ 3 months
Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)/t(16;16) leukemia
Prior hypersensitivity to study drugs or compounds of similar chemical structure
Active uncontrolled infections as determined by the investigator
Active bleeding
Single group
Venetoclax
DrugOrally by mouth
Azacitidine
DrugSubcutaneous injection
Cytarabine
DrugIntravenous infusion
Overall response rate (ORR) after two treatment cycles of induction therapy
Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)
OS: overall survival
time from the date of enrollment to death from any cause or the last follow-up
LFS：leukemia-free survival
the duration from the date of enrollment to the occurrence of treatment failure, relapse, death from any cause, or the last follow-up.
DOR: duration of remission
Time between the first remission and relapse
AE
Adverse events during the induction treatment.
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yuejun Liu
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
