Tests venetoclax with azacitidine in adults newly diagnosed with T-cell leukemia
Tests venetoclax plus azacitidine in people aged 14 or older with newly diagnosed T-cell leukemia.
Plain-language title generated from the registry record
Registry title: Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 14 or older with newly diagnosed early T-cell precursor-like acute lymphoblastic leukemia, T-ALL with myeloid mutations, or T/myeloid mixed phenotype acute leukemia. They get venetoclax with azacitidine.
- Age
- 14 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed ETP-like leukemia, T-ALL with myeloid mutations (for example FLT3, DNMT3A, IDH1/2, RUNX1), or T/myeloid mixed phenotype acute leukemia (T/My-MPAL).
- Earlier treatment
- No earlier induction therapy. Limited earlier treatment is allowed: hydroxyurea, dexamethasone, low-dose cytarabine/venetoclax (total dose <0.5g), and leukocytapheresis.
- Biomarker or test result
- Certain markers on the leukemia cells, for example CD7 positive, CD1a and CD8 negative for ETP-like leukemia. For T-ALL, a myeloid mutation such as FLT3, DNMT3A, STAG2, IDH1/2, RUNX1, EZH2, WT1, ASXL1/2, SF3B1, TET2, BCOR, BCORL1 or MLL-PTD.
Main reasons for not taking part
- Leukemia with gene changes such as t(8;21), t(15;17), inv(16)/t(16;16)
- Active infection that is not under control
- Active bleeding
- Blood clot, embolism or brain bleeding within the last 1 year
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Where in China
- Ethical Committee of the First Affliated Hospital of Soochow UniversitySuzhou, ChinaContact: Zhou-lin LuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- yuejun Liu
- Trial code
- NCT07012447
- Record updated
- 10 June 2025
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: No gender restrictions; Age ≥ 14 years; Confirmed diagnosis of one of the following:; ETP-like leukemia (CD7⁺, CD1a-, CD8-, with CD5 expression stratified as ETP-ALL ≤75% or Near-ETP-ALL >75%) T-cell acute lymphoblastic leukemia (T-ALL) with myeloid mutations (including FLT3, DNMT3A, STAG2, IDH1/2, RUNX1, EZH2, WT1, ASXL1/2, SF3B1, TET2, BCOR, BCORL1, and MLL-PTD) T/myeloid mixed phenotype acute leukemia (T/My-MPAL) (with concurrent T-lineage and myeloid markers, e.g., cCD3⁺/mCD3⁺, CD7⁺, MPO⁺); Newly diagnosed patients without prior induction therapy Limited prior therapy allowed: hydroxyurea, dexamethasone, or low-dose cytarabine/venetoclax (cumulative dose <0.5g), and leukocytapheresis; Expected survival time ≥ 3 months; Liver function: total bilirubin ≤ 2× ULN; ALT/AST ≤ 3× ULN (or ≤ 5× ULN if liver infiltration by leukemia is present) ; Renal function: endogenous creatinine clearance ≥ 30 ml/min; Cardiac function: left ventricular ejection fraction > 45%; Demonstrated capacity to understand the study and willingness to provide informed consent.
Exclusion: Prior hypersensitivity to study drugs or compounds of similar chemical structure; Drug addiction or chronic alcoholism that could interfere with trial evaluation; Active uncontrolled infections as determined by the investigator; Active bleeding; Recent history (within 1 year) of thrombosis, embolism, or cerebral hemorrhage; Psychiatric disorders or other conditions that would prevent obtaining informed consent or compliance with trial requirements; Any condition deemed unsuitable for trial participation by the investigator; Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)/t(16;16) leukemia; Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential.