Status:
UNKNOWN
Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
The Affiliated Jiangning Hospital of Nanjing Medical University
Huai'an First People's Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
Brief 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 Decit...
Detailed Description
This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of Venetoclax combined with Decitabine/Azacitidine and Aclarubicin versus Venetocla...
Eligibility Criteria
Inclusion
- Patients with acute myeloid leukemia (AML) diagnosed by bone marrow morphology and immunophenotyping (in line with WHO 2016 diagnostic criteria);
- No previous anti-acute leukemia treatment (including demethylating drugs), except hydroxyurea and Leukocyte apheresis;
- Exclude acute promyelocytic leukemia (APL) at the bone marrow morphology or molecular level;
- Age 60-80 years old;
- 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;
- LVEF determined by echocardiography≥ 50%;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Obtain informed consent signed by the patient or legal representative.
Exclusion
- Acute promyelocytic leukemia, myeloid sarcoma, accelerated phase and blast of chronic myeloid leukemia;
- Patients with relapsed AML;
- Allergy to any drug involved in the program;
- Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- The liver and kidney functions are obviously abnormal, exceeding the inclusion criteria;
- 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;
- 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);
- AIDS patients, syphilis patients, active type Hepatitis B (HBV-DNA detectable) patients, and Hepatitis C patients;
- 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；
- Inability to understand or comply with the research protocol;
- Received major surgery within 4 weeks before randomization;
- Participate in other clinical investigators at the same time one month before enrollment.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05264883
Start Date
March 1 2021
End Date
February 28 2025
Last Update
May 30 2023
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000