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RECRUITING
NCT07012447
PHASE2

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

Sponsor: yuejun Liu

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-04-01

Completion Date

2028-05-01

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

Orally by mouth

DRUG

Azacitidine

Subcutaneous injection

DRUG

Cytarabine

Intravenous infusion

Locations (1)

Ethical Committee of the First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China