Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations (NCT07012447) | Clinical Trial Compass
RecruitingPhase 2
Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations
China32 participantsStarted 2025-04-01
Plain-language summary
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).
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. No gender restrictions
✓. Age ≥ 14 years
✓. Confirmed diagnosis of one of the following:
✓. 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
✓. Liver function: total bilirubin ≤ 2× ULN; ALT/AST ≤ 3× ULN (or ≤ 5× ULN if liver infiltration by leukemia is present) ; Renal function: endogenous creatinine clearance ≥ 30 ml/min; Cardiac function: left ventricular ejection fraction \> 45%
✓. Demonstrated capacity to understand the study and willingness to provide informed consent
Exclusion criteria
✕. 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
What they're measuring
1
Overall response rate (ORR) after two treatment cycles of induction therapy
Timeframe: time from the date of enrollment to 2 cycles of induction before consolidation therapy（100 days）