RecruitingPhase 3NCT06345365

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)


Sponsor

Zhongnan Hospital

Enrollment

154 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new two-drug combination — magrolimab (MA) and azacitidine (AZA) — for treating newly diagnosed acute myeloid leukemia (AML), a fast-moving blood cancer. The goal is to find out if this regimen is effective and safe, particularly for patients who may not tolerate intensive chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with AML, confirmed by bone marrow tests - Your liver, kidneys, and heart function are within acceptable ranges - Your physical performance level is reasonable (ECOG score 0–2) **You may NOT be eligible if...** - You are allergic to any of the study drugs - You have a concurrent condition called myelofibrosis - You have severe heart disease (such as a recent heart attack or heart failure) - You have an active serious infection or another cancer at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmitoxantrone liposome, Ara-Cytarabine and azacitidine

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

DRUGDaunorubicin,Ara-Cytarabine, azacitidine

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;


Locations(11)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Central Hospital of Huanggang

Huanggang, Hubei, China

The First People's Hospital of Jingzhou

Jingzhou, Hubei, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

Shiyan Taihe Hospital

Shiyan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xianning Central Hospital

Xianning, Hubei, China

The Central Hospital of Xiaogan

Xiaogan, Hubei, China

Yichang Central Hospital

Yichang, Hubei, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Wuxi, Jiangsu, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT06345365


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