NCT06345365RecruitingPhase 3
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 · Last updated 10 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 1 Feb 2024
- Start date
- Jan 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Zhongnan Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06345365
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 154
- From Jan 2024 to the primary completion date, Dec 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant myelofibrosis;
- Concomitant malignant tumours of other organs;
- Previous intolerance or allergy to similar drugs;
- Concurrent participation in other clinical studies;
Other illness
- Allergy or significant contraindication to any of the drugs involved in the protocol;
- Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
- Patients with active tuberculosis and HIV-positive patients;
- Other blood system diseases at the same time;
- Any other condition that prevents the study from proceeding.
Other
- Pregnant or breastfeeding women;
- Inability to understand or comply with the study protocol;
Who the study is looking for
- Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
- Age 18-75 years old;
- 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;
- Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN;
- Physical condition: ECOG score 0-2;
- Obtained informed consent signed by the patient or family.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Central Hospital of Huanggang Coordinator of this site? Confirm its status | Huanggang | China | Not yet recruiting |
| Jingzhou Central Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Not yet recruiting |
| The First People's Hospital of Jingzhou Coordinator of this site? Confirm its status | Jingzhou | China | Not yet recruiting |
| Shiyan Taihe Hospital Coordinator of this site? Confirm its status | Shiyan | China | Not yet recruiting |
| Shanxi Cancer hospital Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Wuxi | China | Not yet recruiting |
| Xianning Central Hospital Coordinator of this site? Confirm its status | Xianning | China | Not yet recruiting |
| The Central Hospital of Xiaogan Coordinator of this site? Confirm its status | Xiaogan | China | Not yet recruiting |
| Yichang Central Hospital Coordinator of this site? Confirm its status | Yichang | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.