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New treatment option for Acute Myeloid Leukemia
Official title Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML
ClinicalTrials.gov ID: NCT06536010
What this study is testing
What is Venetoclax 100 mg d1，200 mg d2，400 mg d3-28；?
Venetoclax 100 mg d1，200 mg d2，400 mg d3-28； is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as AZA 75mg/m2 on days 1-7, G-CSF: 50-600ug/day, starting on day 1 (adjusted based on WBC count of 10-25*10E9/L).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Expected survival of at least 3 months.
You likely can't join 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)...
- Human immunodeficiency virus (HIV) positive.
See the full eligibility 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...
- Expected survival of at least 3 months.
- Ability to understand and willingness to participate in the study, and signing an informed consent form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huai'an, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huai'an, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.