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Condition / disease
Location
Status: Recruiting

Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations

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).

Participants needed: 32
Trial details
Phase: Phase 2Age: 14+Biological sex: AllType: InterventionalSponsor: yuejun LiuUpdated: Jun 10, 2025Locations: 1
Eligibility criteria

No gender restrictions [+5]

Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)/t... [+8]