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

Launched by YUEJUN LIU · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for certain types of leukemia, specifically early T-cell precursor-like acute lymphoblastic leukemia (ETP-like ALL), T-ALL with myeloid mutations, and mixed-phenotype acute leukemia. The combination of two medications, venetoclax and azacitidine, is being tested to see if it can achieve better results than traditional chemotherapy. The trial is open to patients aged 14 and older who have recently been diagnosed with these leukemia types and have not received prior treatment.

Participants in this trial will receive the medications for two cycles of 28 days, along with regular blood tests and scans to monitor their response to the treatment. The main goal is to determine if this new combination is more effective than past treatments. Eligible individuals must meet specific health criteria, such as having a certain level of kidney and liver function and no significant infections. Overall, this trial aims to provide hope for better outcomes in patients facing challenging leukemia diagnoses.

Gender

ALL

Eligibility criteria

• 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