NCT05662956CompletedPhase 2
A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients
Venetoclax/Azacitidine/Low-Dose Cytarabine/Aclarubicin/G-CSF (VA-CAG) in Newly-Diagnosed Acute Myeloid Leukemia: A Phase-2, Multi-center, Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 15 Jul 2025
Brief summary (registry, in English)
This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 10 Dec 2022
- Start date
- Dec 2022
- Primary completion date
- Dec 2024
- Lead sponsor
- Hematology department of the 920th hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05662956
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 114
- From Dec 2022 to the primary completion date, Dec 2024
- 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.
Prior treatment
- Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
Other illness
- Patients with uncontrolled active infection;
- HIV infection;
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment; b) An active second cancer that requires treatment within 6 months of study entry.
Other
- Acute promyeloid leukemia；
- AML with central nervous system (CNS) infiltration；
- Patients with a life expectancy \<3 months
- Female who are pregnant, breast feeding or childbearing potential.
- Patients deemed unsuitable for enrollment by the investigator.
Who the study is looking for
- Patients ≥ 18 years old and ≤ 65 years old
- Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;
- Patients without receiving prior therapy for AML;
- Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
- Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
- Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
- Heart function: left ventricular ejection fraction ≧45%
- Patients must participate in this clinical trial voluntarily and sign an informed consent form.
Age in the registry: 18 years to 65 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 |
|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.