Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Aug 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment involving three medications—Venetoclax, Azacitidine, and Harringtonine—aimed at helping patients with secondary acute myeloid leukemia (sAML). This type of leukemia can occur in patients who have had previous blood disorders or have undergone certain treatments. The researchers want to find out if this new treatment is effective and safe for patients who meet specific criteria.

To participate in this trial, patients must be between 18 and 80 years old and have a recent diagnosis of sAML. They should not have certain serious health conditions, such as central nervous system involvement or active infections like HIV or hepatitis. Participants can expect to receive the combination treatment and will be closely monitored for any side effects and overall effectiveness. Since the trial is currently recruiting, interested patients should talk to their healthcare providers to see if they qualify and to learn more about what participation involves.

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Eligibility criteria

• Inclusion Criteria:
• * 1) Patients with acute myeloid leukemia (AML) newly diagnosed by bone marrow morphology and immunophenotyping (in line with the WHO 2016 diagnostic criteria), and meet any of the following conditions:
• • Patients with treatment-related AML (tAML);
• • AML patients with a previous history of MDS or CMML;
• • AML patients with myelodysplasia-related cytogenetic abnormalities; 2) Age ≥ 18 years old, and age \< 80 years old; 3) Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 4) 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 myocardial enzyme \<2.0×ULN; 5) LVEF determined by echocardiography ≥50%; Obtain informed consent signed by the patient or legal representative.
• Exclusion Criteria:
• • 1) AML with central nervous system (CNS) infiltration; 2) Acute promyelocytic leukemia confirmed by bone marrow morphology or immunophenotyping; 3) Have received Venetoclax treatment in the past; 4) Those who are known to be allergic to any drugs or other ingredients in the program; 5) Currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS; 6) Known human immunodeficiency virus (HIV) infection; 7) Known history of active hepatitis B or C (HBV, HCV) infection; 8) Pregnant women and women who are trying to conceive; 9) Suffering from severe and/or uncontrolled mental illness; 10) Any life-threatening disease, health condition, or organ system dysfunction that the investigator believes may compromise the safety of the subject, or create an undue risk to the research results; 11) Received major surgery within 4 weeks before randomization; Participate in other clinical investigators at the same time one month before enrollment