Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

NCT07486479 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CSPC-DED-AML-K23
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 21

Brief Summary

This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute myeloid leukemia; mitoxantrone hydrochloride liposome; Venetoclax; Azacitidine; Idarubicin; Cytarabine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission(CRc) rate after one cycle of induction therapy

  Complete remission plus complete remission with partial hematologic recovery plus complete remission with incomplete hematologic recovery (CR+CRh+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

  At the end of the first treatment cycle (Day 28 ± 7), each cycle is 28 days).

Secondary Outcomes (11)

• Measurable residual disease (MRD) negativity rate (by flow cytometry and molecular testing) among patients who achieved CRc after induction therapy

  At the end of each cycle (Day 28 ± 7), each cycle is 28 days, up to 2 cycles.

• Overall response rate(ORR) to induction therapy

  At the end of each cycle (Day 28 ± 7), each cycle is 28 days, up to 2 cycles

• Time to CRc

  Within 100 days from day 1 of treatment.

• 1-year relapsed-free survival (RFS) rate

  up to 1 years after the date of the last enrolled participants

• 1-year leukemia-free survival (LFS) rate

  up to 1 years after the date of the last enrolled participants

Study Arms (2)

MVA

EXPERIMENTAL

Patients achieving complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) after Cycle 1 proceed to consolidation therapy. Patients achieving a partial response (PR) or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same MVA regimen. Those who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation. Patients with no response (NR) after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.

Drug: Mitoxantrone Hydrochloride Liposome; Drug: Venetoclax; Drug: Azacitidine

IA

ACTIVE COMPARATOR

Patients achieving CR, CRh, CRi, or MLFS after Cycle 1 proceed to consolidation therapy. Patients achieving a PR or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same IA regimen. Those who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation. Patients with NR after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.

Drug: Idarubicin; Drug: Cytarabine

Interventions

Mitoxantrone Hydrochloride Liposome DRUG

Mitoxantrone Hydrochloride Liposome: 24 mg/m², administered by intravenous drip (ivgtt) on day 1

MVA

Venetoclax DRUG

Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)

MVA

Azacitidine DRUG

Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7

MVA

Idarubicin DRUG

Idarubicin: 12 mg/m², administered by intravenous drip (ivgtt) on days 1-3

IA

Cytarabine DRUG

Cytarabine: 100 mg/m², administered by intravenous drip (ivgtt) on days 1-7

IA

Eligibility Criteria

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

You may qualify if:

• \. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).
• \. Aged 18 to 65 years, any gender. 3. Newly diagnosed with AML according to the 2022 WHO classification. 4. Eligible for intensive chemotherapy as determined by the investigator. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6. Life expectancy ≥ 3 months. 7. Adequate liver and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5 × ULN for patients with hepatic involvement); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with hepatic involvement); serum creatinine ≤ 1.5 × ULN.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Any of the following conditions:
• Acute promyelocytic leukemia (APL);
• Central nervous system leukemia (CNSL);
• AML secondary to chemotherapy/radiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML);
• Prior treatment with hypomethylating agents (HMA) or venetoclax;
• Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis);
• History of other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies that have been effectively controlled without treatment in the past five years);
• Inability to take oral medication or malabsorption syndrome;
• Cardiac function or disease meeting any of the following criteria:
• Long QTc syndrome or QTc interval \> 480 ms;
• Complete left bundle branch block, second- or third-degree atrioventricular block;
• Severe, uncontrolled arrhythmias requiring medication;
• New York Heart Association (NYHA) Class ≥ II;
• Left ventricular ejection fraction (LVEF) \< 50%;

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: collaborator

Study Sites (21)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 41003, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

Changzhou First People's Hospital

Changzhou, Jiangsu, 213003, China

Location

Huai'an Second People's Hospital

Huai'an, Jiangsu, 223002, China

Location

Jingjiang People's Hospital

Jingjiang, Jiangsu, 214500, China

Location

The First People's Hospital Of Lianyungang

Lianyungang, Jiangsu, 222002, China

Location

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222006, China

Location

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

YanCheng NO.1 People's Hospital

Yancheng, Jiangsu, 224006, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine; Idarubicin; Cytarabine

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; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Arabinonucleosides

Study Officials

• Depei Wu

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Tang

CONTACT

0512-67780103; tangxiaowen@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: March 20, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (21)