Combination treatment of low-dose decitabine and venetoclax for elderly patients with AML and MDS

A Multi-center Prospective Single Arm Clinical Study of Prolonged Ultra Low-dose Decitabine Combined With Venetoclax (Bcl-2 Inhibitor) as First Line Treatment for Elderly Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes

This study is testing if a new combination of low-dose decitabine and venetoclax can help older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes feel better and have better treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06046313 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of a prolonged low-dose regimen of decitabine combined with venetoclax in elderly patients diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). The treatment aims to improve outcomes for patients who typically have poor responses to traditional chemotherapy and limited treatment options. By utilizing a combination of a demethylating agent and a Bcl-2 inhibitor, the study seeks to enhance complete remission rates and reduce treatment-related risks. The trial will expand on previous pilot findings by including a larger, multi-center patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 60 and older who have been newly diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome.

Not a fit: Patients younger than 60 years old or those who have previously received treatment for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates and survival outcomes for elderly patients with AML and high-risk MDS.

How similar studies have performed: Previous studies have shown promising results with similar combinations of demethylating agents and Bcl-2 inhibitors, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission.

   Diagnostic criteria refer to 2016 WHO classification.
2. Age 60 or older.
3. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1).
4. Creatinine clearance ≥30 mL/min(as assessed by the Cockcrod-Gault formula \[Cockcroft et al 1976\] \[13\] or the estimated glomerular filtration rate \[eGFR\] from the Kidney Drink adjustment formula .
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
6. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016).
7. Life expectancy \>8 weeks.
8. Sign the informed consent voluntarily, and understand and comply with the requirements of the study.

Exclusion Criteria:

1. Age \<60 years old.
2. Treated patients who had received various chemotherapy regiments.
3. Present clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale (see Appendix 2), or history of myocardial infarction in the 6 months prior to screening.
4. Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes).
5. Those who cannot understand and follow the research plan or sign the informed consent.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Weiyan Zheng, MD — Zhejiang University
• Study coordinator: Weiyan Zheng, MD

Conditions Acute Myeloid Leukemia; Myelodysplastic Syndromes