HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL). (NCT07517510) | Clinical Trial Compass
By InvitationPhase 2
HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL).
China40 participantsStarted 2026-04-01
Plain-language summary
This study aims to evaluate the safety and efficacy of homoharringtonine combined with venetoclax and azacitidine regimen (HVA) in newly diagnosed MPAL patients, providing a basis for the use of the HVA regimen in the treatment of MPAL.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF);
✓. Age ≥18 years;
✓. Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification.
✓. The patient has not started anti-leukemia treatment after the initial diagnosis (except cytoreductive therapy, such as hydroxyurea or cytarabine \<1.0 g/day or glucocorticoids);
✓. Expected survival ≥12 weeks;
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
✓. Normal cardiac function, left ventricular ejection fraction ≥50%; normal renal function: creatinine clearance ≥30 ml/min; normal liver function: ALT \<5 times the normal value, bilirubin \<3 times the normal value;
Exclusion criteria
✕. Patients who have had or currently have other malignant tumors requiring treatment;
✕. Patients with central nervous system (CNS) infiltration;
✕. Other clinically significant uncontrolled conditions, including but not limited to: (1) uncontrolled or active systemic infections (viral, bacterial, or fungal); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) uncontrolled hypertension, etc.;
✕. Patients who cannot take oral medications or have malabsorption syndrome;
What they're measuring
1
Composite Complete Remission (CRc)
Timeframe: At the end of cycle 2 (28 days for a cycle)
Trial details
NCT IDNCT07517510
SponsorGuangdong Second Provincial General Hospital
✕. Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients;
✕. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study;
✕. Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol;
✕. Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias;