Clinical trial · Interventional
HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL).
The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine (HVA) in the Treatment of Mixed-Phenotype Acute Leukemia (MPAL), a Multicenter, Prospective, Single-arm Trial
NCT07517510CI-TRIAL-00107625HVA-MPALenrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL) | Mixed Phenotype Acute Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HVA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HVA regiment
- description
- HVA regiment for newly diagnosed MPAL
- interventionNames
- Drug: HVA
Primary outcomes (1)
- measure
- Composite Complete Remission (CRc)
- timeFrame
- At the end of cycle 2 (28 days for a cycle)
- description
- The rate of composite complete remission including complete remission (CR) and CR with incomplete blood count recovery (CRi)
Secondary outcomes (4)
- measure
- Complete remission (CR)
- timeFrame
- At the end of cycle 2 (28 days for a cycle)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF); 2. Age ≥18 years; 3. Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification. 4. 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); 5. Expected survival ≥12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 7. 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: 1. Patients who have had or currently have other malignant tumors requiring treatment; 2. Patients with central nervous system (CNS) infiltration; 3. 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.; 4. Patients who cannot take oral medications or have malabsorption syndrome; 5. Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients; 6. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study; 7. Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol; 8. Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias; 9. Patients known to be infected with human immunodeficiency virus (HIV); patients with active hepatitis B or C; subjects who are inactive hepatitis carriers or whose viral hepatitis titers are low after treatment with non-prohibited antiviral drugs are not excluded; 10. Patients who cannot take oral medications or have malabsorption syndrome; 11. Patients whom the investigator determines are unsuitable to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.