Treatment of secondary acute myeloid leukemia with a new drug combination

Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of Secondary Acute Myeloid Leukemia

This study is testing a new combination of drugs to see if it can help people with secondary acute myeloid leukemia feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05513131 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination therapy involving Venetoclax, Azacitidine, and Harringtonine in patients diagnosed with secondary acute myeloid leukemia (sAML). The study is open-label and single-center, focusing on administering 1-2 cycles of intensive treatment followed by consolidation therapy. Participants will be monitored for treatment response and may undergo allogeneic hematopoietic stem cell transplantation if eligible. Follow-up assessments will occur every three months for up to two years post-treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with newly diagnosed sAML or treatment-related AML.

Not a fit: Patients with acute promyelocytic leukemia or those with central nervous system infiltration will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with secondary acute myeloid leukemia.

How similar studies have performed: Other studies have shown promise with similar drug combinations in treating acute myeloid leukemia, but this specific combination is novel.

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

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Huang Fei, MD

Conditions Secondary Acute Myeloid Leukemia