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

Sponsor
yuejun Liu
Study ID
NCT07012447
Phase
PHASE2
Status
Recruiting
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Conditions

  • Early T Acute Lymphoblastic Leukemia
  • Mixed Phenotype Acute Leukemia, T/Myeloid, Nos
  • T-Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Orally by mouth
  • Azacitidine — DRUG
    Subcutaneous injection
  • Cytarabine — DRUG
    Intravenous infusion

Study Details

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).

Key Dates

Start date
Apr 1, 2025
Status verified
Jun 2025
Primary completion
Apr 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational ( venetoclax, azacytidine)
    Two cycles induction as venetoclax (oral, 100 mg D1, 200 mg D2, 400 mg D3-28) and azacitidine (75 mg/m² SC D1-7); Consolidation: For fit patients, if those with MRD (Minimal Residual Disease) are negative or refuse to undergo allo-HSCT (Hematopoietic stem-cell transplantation), intermediate-dose (2g/m² q12h, days 1-3) cytarabine-based therapy is administered for 3-4 cycles; if patients are MRD-positive, they undergo allo-HSCT. For unfit patients, each venetoclax combined with azacitidine treatment cycle is anticipated to be 28 days in length until progression of disease, although cycle delays may occur due to delayed blood count recovery.

Primary Outcome Measure

Overall response rate (ORR) after two treatment cycles of induction therapy [ Time Frame: time from the date of enrollment to 2 cycles of induction before consolidation therapy（100 days） ]

Central Contacts