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

NCT07012447 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-06-10

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Venetoclax

Orally by mouth

DRUG

Azacitidine

Subcutaneous injection

DRUG

Cytarabine

Intravenous infusion

Sponsors & Collaborators

  • yuejun Liu

    lead OTHER

Principal Investigators

  • Yue-jun Liu · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-04-01
Completion
2028-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07012447 on ClinicalTrials.gov