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

NCT06345365 | Recruiting Phase 3 DMC

• 1 other identifier: 09
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 11

Brief 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

Keywords

Mitoxantrone liposome; Newly diagnosed AML patients; Ara-Cytarabine; Azacytidine

Outcome Measures

Primary Outcomes (1)

• Complete remission rate

  Bone marrow primitive cells \<5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L.

  Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

Secondary Outcomes (8)

• Incidence of adverse events

  Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

• Compound CR rate

  Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

• Objective remission rate

  Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

• No remission rate

  Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

• Event-free survival

  Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any caus)

Study Arms (2)

mitoxantrone liposome, Ara-Cytarabine and azacitidine

EXPERIMENTAL

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: mitoxantrone liposome, Ara-Cytarabine and azacitidine

Daunorubicin, Ara-Cytarabine and azacitidine

ACTIVE COMPARATOR

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;

Drug: Daunorubicin,Ara-Cytarabine, azacitidine

Interventions

mitoxantrone liposome, Ara-Cytarabine and azacitidine DRUG

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

mitoxantrone liposome, Ara-Cytarabine and azacitidine

Daunorubicin,Ara-Cytarabine, azacitidine DRUG

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;

Daunorubicin, Ara-Cytarabine and azacitidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 ≤ 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.

You may not qualify 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;
• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead
• Ruijin Hospital: collaborator
• Shanxi Province Cancer Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Jingzhou Central Hospital: collaborator
• Yichang Central People's Hospital: collaborator
• Taihe Hospital: collaborator
• Central Hospital of Xiaogan: collaborator
• Xianning Central Hospital: collaborator
• The First People's Hospital of Jingzhou: collaborator

Study Sites (11)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

The Central Hospital of Huanggang

Huanggang, Hubei, 438000, China

NOT YET RECRUITING

The First People's Hospital of Jingzhou

Jingzhou, Hubei, 434000, China

NOT YET RECRUITING

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

NOT YET RECRUITING

Shiyan Taihe Hospital

Shiyan, Hubei, 442000, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Xianning Central Hospital

Xianning, Hubei, 437100, China

NOT YET RECRUITING

The Central Hospital of Xiaogan

Xiaogan, Hubei, 432100, China

NOT YET RECRUITING

Yichang Central Hospital

Yichang, Hubei, 443003, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Wuxi, Jiangsu, 214028, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030009, China

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Fuling Zhou

  Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Fuling Zhou, Doctor

CONTACT

027-67813137; zhoufuling@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: April 3, 2024
• Study Start: January 18, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)