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

NCT06345365 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-04-10

No results posted yet for this study

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).

Conditions

  • Acute Myeloid Leukaemia

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;

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Jingzhou Central Hospital

    collaborator OTHER

  • Yichang Central People's Hospital

    collaborator OTHER

  • Taihe Hospital

    collaborator OTHER

  • Central Hospital of Xiaogan

    collaborator OTHER

  • Xianning Central Hospital

    collaborator OTHER

  • The First People's Hospital of Jingzhou

    collaborator OTHER

  • Zhongnan Hospital

    lead OTHER

Principal Investigators

  • Fuling Zhou · Wuhan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06345365 on ClinicalTrials.gov