Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML

Recruiting now · Not applicable

Conditions studied: Acute Myeloid Leukemia

In brief

This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML). The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.

Key facts

Study ID

NCT06536010

Run by

Yang Xiaotian

People needed

50

Starts

2021-11-03

Expected to finish

2028-07-31

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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