Using Venetoclax with Azacitidine to treat elderly patients with Acute Myeloid Leukemia

The Second Affiliated Hospital of Kunming Medical University

This study is testing if combining the drugs Venetoclax and azacitidine can help older patients with Acute Myeloid Leukemia feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 60 Years and up
• Sex: Female
• Sponsor: The Second Affiliated Hospital of Kunming Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT05949762 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective phase II, single-arm study aimed at evaluating the efficacy of Venetoclax in combination with azacitidine and HA regimens in elderly patients aged over 60 with primary Acute Myeloid Leukemia (AML). The study plans to enroll 45 patients diagnosed with AML and will assess treatment responses based on established prognostic criteria. Patients will undergo induction therapy followed by consolidation and maintenance treatments, with specific protocols for those who do not achieve desired treatment responses. The trial seeks to optimize treatment regimens for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged over 60 with primary Acute Myeloid Leukemia who meet specific diagnostic and health criteria.

Not a fit: Patients with acute promyelocytic leukemia or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for elderly patients suffering from Acute Myeloid Leukemia.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations in AML, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. patients with acute myeloid leukemia other than APL who meet the World Health Organization diagnostic criteria (WHO 2016 criteria);
2. those with AML not otherwise classified under the World Health Organization AML classification except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma.
3. Age \> 60 years, male or female.
4. Have a score of 0-2 on the Eastern Cooperative Oncology Group Physical Status Scale (ECOG-PS).
5. pass the requirements of the following laboratory test indicators (performed within 7 days prior to treatment): 1) Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN), serum bilirubin ≤ 2 x ULN; serum cardiac enzymes \< 2.0 x ULN; serum creatinine ≤ 2.0 x ULN; 2) Cardiac ejection fraction within normal values as determined by cardiac ultrasound (ECHO).
6. Informed consent had to be signed before all specific study procedures were started, and the informed consent was signed by the patient himself/herself or his/her immediate family members; in view of the patient's condition, if the signature of the patient himself/herself was not conducive to the treatment of his/her condition, the informed consent was signed by his/her legal guardian or the patient's immediate family members.

Exclusion Criteria:

1、Treated patients (is defined as having received induction chemotherapy in the past, regardless of the efficacy).

2, Concurrent malignant tumors of other organs (those requiring treatment). 3, Patients participating in the trial must use contraception during the trial treatment and within 3 years after completion of treatment.

4, Significantly abnormal liver and kidney function beyond the enrollment criteria.

5. Active heart disease, defined as one or more of the following:

1. History of uncontrolled or symptomatic angina;
2. Myocardial infarction less than 6 months from study entry;
3. A history of arrhythmia requiring medication or clinically significant symptoms;
4. Uncontrolled or symptomatic congestive heart failure (\> NYHA class 2);
5. Ejection fraction below the lower limit of the normal range. 6. severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).

7) Those deemed unsuitable for enrollment by the investigator

Where this trial is running

Kunming, Yunnan

• The Second Affiliated Hospital of Kunming Medical University. — Kunming, Yunnan, China (Recruiting)

Study contacts

• Study coordinator: yaxian tan

Conditions Acute Myeloid Leukemia