Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML

• Status: Recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia.

This study involves the following:

Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Huai'an First People's Hospital; The Affiliated Jiangning Hospital of Nanjing Medical University; Yancheng First People's Hospital
• Treatments: Aclarubicin; Azacitidine; Decitabine; Venetoclax

Criteria

Inclusion Criteria:

1. Patients with acute myeloid leukemia (AML) diagnosed by bone marrow morphology and immunophenotyping (in line with WHO 2016 diagnostic criteria);

2. No previous anti-acute leukemia treatment (including demethylating drugs), except hydroxyurea and Leukocyte apheresis;

3. Exclude acute promyelocytic leukemia (APL) at the bone marrow morphology or molecular level;

4. Age 60-80 years old;

5. Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP)≤ 3×upper limit of normal (ULN), serum bilirubin≤ 1.5×ULN; serum creatinine≤ 2.0×ULN; serum heart rate≤ 2.0×ULN;

6. LVEF determined by echocardiography≥ 50%;

7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;

8. Obtain informed consent signed by the patient or legal representative.

Exclusion Criteria:

1. Acute promyelocytic leukemia, myeloid sarcoma, accelerated phase and blast of chronic myeloid leukemia;

2. Patients with relapsed AML;

3. Allergy to any drug involved in the program;

4. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;

5. The liver and kidney functions are obviously abnormal, exceeding the inclusion criteria;

6. Structural heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart disease, heart failure or myocardial infarction within 6 months prior to screening, resulting in clinical symptoms or abnormal cardiac function;

7. Suffering from other malignant tumors at the same time; except for the following cases: ①Have received treatment for the purpose of cure, and have no known active malignance for ≥5 years before enrollment; ② Adequately treated non-melanoma skin cancer or malignant lentigo with no signs of disease (even if less than 3 years before randomization); ③ Adequately treated carcinoma in situ with no signs of disease (even if less than 3 years before randomization);

8. AIDS patients, syphilis patients, active type Hepatitis B (HBV-DNA detectable) patients, and Hepatitis C patients;

9. Any concurrent medical condition or disease (such as active systemic infection) that may interfere with study procedures or results, or which, in the judgment of the investigator, poses a risk to participation in this study；

10. Inability to understand or comply with the research protocol;

11. Received major surgery within 4 weeks before randomization;

12. Participate in other clinical investigators at the same time one month before enrollment.