Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06345365

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

Led by Zhongnan Hospital · Updated on 2024-04-10

154

Participants Needed

11

Research Sites

258 weeks

Total Duration

On this page

Sponsors

Z

Zhongnan Hospital

Lead Sponsor

R

Ruijin Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary AML confirmed by bone marrow morphology and immunology
  • Age between 18 and 75 years
  • Liver function: total bilirubin ≤1.5 times upper limit of normal (ULN), AST/ALT <2 times ULN
  • Kidney function: serum creatinine <1.5 times ULN, creatinine clearance between 80 and 120 ml/min
  • Cardiac function: ejection fraction ≥50%, ultrasensitive troponin and natriuretic peptide <1.5 times ULN
  • Physical condition with ECOG score 0 to 2
  • Signed informed consent obtained from patient or family
Not Eligible

You will not qualify if you...

  • Allergy or significant contraindication to any study drugs
  • Presence of myelofibrosis
  • Severe cardiac disease including myocardial infarction or cardiac insufficiency
  • Other malignant tumors in different organs
  • Active tuberculosis or HIV-positive status
  • Other blood system diseases concurrently
  • Pregnant or breastfeeding women
  • Inability to understand or follow the study protocol
  • Previous intolerance or allergy to similar drugs
  • Participation in other clinical studies concurrently
  • Any other condition preventing study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Not Yet Recruiting

2

The Central Hospital of Huanggang

Huanggang, Hubei, China, 438000

Not Yet Recruiting

3

The First People's Hospital of Jingzhou

Jingzhou, Hubei, China, 434000

Not Yet Recruiting

4

Jingzhou Central Hospital

Jingzhou, Hubei, China, 434020

Not Yet Recruiting

5

Shiyan Taihe Hospital

Shiyan, Hubei, China, 442000

Not Yet Recruiting

6

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

7

Xianning Central Hospital

Xianning, Hubei, China, 437100

Not Yet Recruiting

8

The Central Hospital of Xiaogan

Xiaogan, Hubei, China, 432100

Not Yet Recruiting

9

Yichang Central Hospital

Yichang, Hubei, China, 443003

Not Yet Recruiting

10

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Wuxi, Jiangsu, China, 214028

Not Yet Recruiting

11

Shanxi Cancer Hospital

Taiyuan, Shanxi, China, 030009

Not Yet Recruiting

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Research Team

F

Fuling Zhou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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