RecruitingPhase 2NCT07012447

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

Evaluating the Efficacy of Venetoclax Combined With Azacitidine Induction Therapy of Early T-cell Precursor-like Acute Lymphoblastic Leukemia and T-ALL With Myeloid Mutations


Sponsor

yuejun Liu

Enrollment

32 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of venetoclax (a targeted drug that triggers cancer cell death) and azacitidine (a chemotherapy drug) for a rare and aggressive type of blood cancer called ETP-like leukemia or T-cell acute lymphoblastic leukemia with specific gene mutations. **You may be eligible if...** - You are 14 or older (no gender restrictions) - You have a confirmed diagnosis of ETP-like leukemia, T-ALL with myeloid mutations, or T/myeloid mixed phenotype acute leukemia - Your diagnosis has been confirmed by bone marrow testing and genetic analysis **You may NOT be eligible if...** - You have significant organ failure (heart, liver, or kidney) - You have active serious infections - You are pregnant or breastfeeding - You have previously received treatments that conflict with study drug protocols Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Orally by mouth

DRUGAzacitidine

Subcutaneous injection

DRUGCytarabine

Intravenous infusion


Locations(1)

Ethical Committee of the First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07012447