Venetoclax plus azacitidine for newly diagnosed ETP-like and myeloid-mutated T-cell ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm Phase II trial gives two 28-day induction cycles of oral venetoclax (ramped to 400 mg daily) plus subcutaneous azacitidine (75 mg/m² days 1–7) to newly diagnosed patients with ETP-like ALL, T-ALL with myeloid mutations, or T/My-MPAL. Responses are measured after cycle 1 (days 22–35) and after cycle 2 by bone marrow morphology, flow cytometry, and molecular testing, and overall response rate (CR + CRi) will be compared to historical controls. Patients who do not achieve at least a partial remission after cycle 1 or a CR/CRi after cycle 2 will discontinue protocol therapy and move to alternative consolidation or maintenance as appropriate. Safety is monitored closely under NCI-CTCAE v5.0 with predefined dose modifications and stopping rules.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. No gender restrictions
2. Age ≥ 14 years
3. 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⁺)
4. Newly diagnosed patients without prior induction therapy Limited prior therapy allowed: hydroxyurea, dexamethasone, or low-dose cytarabine/venetoclax (cumulative dose \<0.5g), and leukocytapheresis
5. Expected survival time ≥ 3 months
6. 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%
7. Demonstrated capacity to understand the study and willingness to provide informed consent

Exclusion Criteria:

1. Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)/t(16;16) leukemia
2. Prior hypersensitivity to study drugs or compounds of similar chemical structure
3. Active uncontrolled infections as determined by the investigator
4. Active bleeding
5. Recent history (within 1 year) of thrombosis, embolism, or cerebral hemorrhage
6. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
7. Drug addiction or chronic alcoholism that could interfere with trial evaluation
8. Psychiatric disorders or other conditions that would prevent obtaining informed consent or compliance with trial requirements
9. Any condition deemed unsuitable for trial participation by the investigator

Where it's running

• Ethical Committee of the First Affliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Yue-jun Liu — The First Affiliated Hospital of Soochow University
• Study coordinator: Yue-jun Liu
• Email: liuyuejun@suda.edu.cn
• Phone: 008613915535177

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.