Using VAG regimen to treat newly diagnosed acute myeloid leukemia

Clinical Trial Protocol for the Combined Use of Azacitidine, Venetoclax, and Granulocyte Colony-Stimulating Factor in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) (Phase IIb, Single-arm, Prospective, Single-center Study)

This study is testing a new treatment called the VAG regimen for people with newly diagnosed acute myeloid leukemia to see if it works better than standard chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second People's Hospital of Huai'an (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Huai'an, Jiangsu)
• Trial ID: NCT06536010 on ClinicalTrials.gov

What this trial studies

This clinical efficacy study evaluates the VAG regimen, which combines azacitidine and venetoclax with granulocyte colony-stimulating factor, for treating newly diagnosed acute myeloid leukemia (AML). It is a single-arm, prospective, single-center phase IIb study aimed at assessing the efficacy and safety of this treatment approach. The study seeks to explore the synergistic mechanisms of the VAG regimen in combating AML, particularly in patients who may not respond well to traditional chemotherapy. Given the aggressive nature of AML and the low survival rates, this study addresses a critical need for more effective treatment options.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who have been diagnosed with acute myeloid leukemia and meet specific health criteria.

Not a fit: Patients with acute promyelocytic leukemia, central nervous system leukemia, or severe uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with newly diagnosed acute myeloid leukemia.

How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 75 years, regardless of gender.
* Diagnosis of AML (excluding APL) according to the 2022 World Health Organization (WHO) diagnostic criteria.
* ECOG performance status of 0-2.
* For female participants of childbearing potential or male participants with female partners of childbearing potential, effective contraceptive measures must be taken throughout the entire treatment period and for 6 months after the treatment period.
* Expected survival of at least 3 months.
* Ability to understand and willingness to participate in the study, and signing an informed consent form.

Exclusion Criteria:

* Acute promyelocytic leukemia (M3 subtype).
* Central nervous system leukemia.
* Severe uncontrolled infection or other major diseases.
* Heart failure: Ejection fraction (EF) \< 50%, New York Heart Association (NYHA) class II or above.
* Impaired liver or kidney function: Serum total bilirubin ≥ 2.0 mg/dl, AST ≥ 3 times the upper limit of normal, serum creatinine clearance rate (Ccr) ≥ 50 ml/min, arterial oxygen saturation (SpO2) \< 92%.
* Human immunodeficiency virus (HIV) positive.
* Active hepatitis B or C.
* Pregnant or lactating women.
* Other conditions in which the investigator deems the participant unsuitable for the study.

Where this trial is running

Huai'an, Jiangsu

• Huai'an Second People's Hospital — Huai'an, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiaotian Yang

Conditions Acute Myeloid Leukemia