NCT06536010Recruiting
Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML
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)
Source: ClinicalTrials.gov · Last updated 2 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 3 Nov 2021
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Yang Xiaotian
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06536010
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 3 Nov 2021 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe uncontrolled infection or other major diseases.
- Human immunodeficiency virus (HIV) positive.
- Active hepatitis B or C.
- Other conditions in which the investigator deems the participant unsuitable for the study.
Lab values
- 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%.
Other
- Acute promyelocytic leukemia (M3 subtype).
- Central nervous system leukemia.
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huai'an Second People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.