RecruitingNot ApplicableNCT06536010
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)
Sponsor
Yang Xiaotian
Enrollment
50 participants
Start Date
Nov 3, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 Criteria9
- 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.
Interventions
DRUGVenetoclax 100 mg d1，200 mg d2，400 mg d3-28；
VAG in the induction phase of the ND-AML treatment protocol
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06536010
Related Trials
Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
NCT05554406216 locations
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
NCT06672146112 locations
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
NCT05554393175 locations
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
NCT06317649218 locations
Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML
NCT065142614 locations