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RECRUITING
NCT06345365
PHASE3

MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

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).

Official title: A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2024-01-18

Completion Date

2028-12-31

Last Updated

2024-04-10

Healthy Volunteers

No

Interventions

DRUG

mitoxantrone 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

DRUG

Daunorubicin,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