Clinical trial · Interventional
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
- 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)
Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine).
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 |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daunorubicin,Ara-Cytarabine, azacitidine | Drug | — | UNRESOLVED |
| mitoxantrone liposome, Ara-Cytarabine and azacitidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mitoxantrone liposome, Ara-Cytarabine and azacitidine
- description
- Mitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;
- interventionNames
- Drug: mitoxantrone liposome, Ara-Cytarabine and azacitidine
- type
- ACTIVE_COMPARATOR
- label
- Daunorubicin, Ara-Cytarabine and azacitidine
- description
- Daunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3 Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;
- interventionNames
- Drug: Daunorubicin,Ara-Cytarabine, azacitidine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow; 2. Age 18-75 years old; 3. Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT \<2 × ULN, serum creatinine \<1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min; 4. Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN; 5. Physical condition: ECOG score 0-2; 6. Obtained informed consent signed by the patient or family. Exclusion Criteria: 1. Allergy or significant contraindication to any of the drugs involved in the protocol; 2. Patients with concomitant myelofibrosis; 3. Severe cardiac disease, including myocardial infarction and cardiac insufficiency; 4. Concomitant malignant tumours of other organs; 5. Patients with active tuberculosis and HIV-positive patients; 6. Other blood system diseases at the same time; 7. Pregnant or breastfeeding women; 8. Inability to understand or comply with the study protocol; 9. Previous intolerance or allergy to similar drugs; 10. Concurrent participation in other clinical studies; 11. Any other condition that prevents the study from proceeding.
References
Publications (0)
Data not yet available