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New treatment option for Acute Myeloid Leukaemia
Official title MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT06345365
What this study is testing
What is mitoxantrone liposome, Ara-Cytarabine and azacitidine?
mitoxantrone liposome, Ara-Cytarabine and azacitidine is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute myeloid leukaemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 ≤...
- Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN;
- Physical condition: ECOG score 0-2;
You likely can't join if
- Allergy or significant contraindication to any of the drugs involved in the protocol;
- Patients with concomitant myelofibrosis;
- Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
- Concomitant malignant tumours of other organs;
- Patients with active tuberculosis and HIV-positive patients;
- Other blood system diseases at the same time;
See the full eligibility criteria
- 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.
- Allergy or significant contraindication to any of the drugs involved in the protocol;
- Patients with concomitant myelofibrosis;
- Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
- Concomitant malignant tumours of other organs;
- Patients with active tuberculosis and HIV-positive patients;
- Other blood system diseases at the same time;
- Pregnant or breastfeeding women;
- Inability to understand or comply with the study protocol;
- Previous intolerance or allergy to similar drugs;
- Concurrent participation in other clinical studies;
- Any other condition that prevents the study from proceeding.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Huanggang, Hubei, China
- Jingzhou, Hubei, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Xianning, Hubei, China
- Xiaogan, Hubei, China
- Yichang, Hubei, China
- Wuxi, Jiangsu, China
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Huanggang, Hubei, China; Jingzhou, Hubei, China; Shiyan, Hubei, China; Wuhan, Hubei, China; Xianning, Hubei, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.