Using VAG regimen to treat newly diagnosed acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xiaotian Yang
• Email: 15695110492@163.com
• Phone: 15695110492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.