drugset / Trial / NCT06345365
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Phase 3
Recruiting
154 enrolled
Zhongnan Hospital
Central Hospital of Xiaogan · collabJingzhou Central Hospital · collabRuijin Hospital · collabShanxi Province Cancer Hospital · collabTaihe Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First People's Hospital of Jingzhou · collabXianning Central Hospital · collabYichang Central People's Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
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).
Timeline
- Start
- 2024-01-18
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | 100 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 24 mg/m2 | Intravenous |