NCT06536010 Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML
| NCT ID | NCT06536010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yang Xiaotian |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-11-03 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2021-11-03 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06536010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06536010 currently recruiting?
Yes, NCT06536010 is actively recruiting participants. Contact the research team at 15695110492@163.com for enrollment information.
Where is the NCT06536010 trial being conducted?
This trial is being conducted at Huai'an, China.
Who is sponsoring the NCT06536010 clinical trial?
NCT06536010 is sponsored by Yang Xiaotian. The trial plans to enroll 50 participants.
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