A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients (NCT05662956) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients
China114 participantsStarted 2022-12-01
Plain-language summary
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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Heart function: left ventricular ejection fraction ≧45%
. Patients must participate in this clinical trial voluntarily and sign an informed consent form.
Exclusion criteria
. Acute promyeloid leukemia；
. AML with central nervous system (CNS) infiltration；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CR rate
Timeframe: At the end of Cycle 1 of induction (each cycle is about 30 days)
Trial details
NCT IDNCT05662956
SponsorHematology department of the 920th hospital
. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
. Patients with a life expectancy \<3 months
. 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.
. Female who are pregnant, breast feeding or childbearing potential.