Venetoclax added to cytarabine after remission in acute myeloid leukemia
Compares venetoclax plus cytarabine with cytarabine alone in adults with acute myeloid leukemia in remission.
Plain-language title generated from the registry record
Registry title: VEN+IDAC vs IDAC in AML
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with acute myeloid leukemia (AML) who are in remission after first treatment. It compares venetoclax plus cytarabine with cytarabine alone.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia (AML) in complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction therapy. ECOG performance status of 2 or less.
- Earlier treatment
- Must have had induction therapy and reached remission. No major surgery, radiation, other chemotherapy or investigational drugs within 3 weeks before the study drug.
- Biomarker or test result
- A baseline MRD test (multiparameter flow cytometry, MFC) must be done at enrollment. Liver, kidney and heart function must be basically normal (LVEF 50% or higher).
Main reasons for not taking part
- Another active cancer
- Leukemia in the central nervous system
- Uncontrolled severe infection, or active hepatitis B, hepatitis C or HIV infection
- Severe heart disease, such as a heart attack in the past 6 months
- Pregnant or breastfeeding women, or known allergy to venetoclax or cytarabine
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07537257, who can take part
Where in China
- Department of Hematology, Guangdong Second Provincial General HospitalGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Guangdong Second Provincial General Hospital
- Trial code
- NCT07537257
- Record updated
- 17 April 2026
- Original description
This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.Read full original descriptionShow less
Venetoclax Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine for Consolidation Therapy of Acute Myeloid Leukemia (AML): a Multicenter, Prospective, Randomized Controlled, Phase 2 Study
This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.
Inclusion: Age between 18 and 65 years, any gender; Meet the WHO 2022 diagnostic criteria for acute myeloid leukemia (AML), and achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction therapy. CR is defined as bone marrow blasts ≤5%, absolute neutrophil count ≥1.0×10⁹/L, and platelets ≥100×10⁹/L; CRi is defined as bone marrow blasts ≤5%, absolute neutrophil count ≥0.5×10⁹/L, and platelets ≥50×10⁹/L; Baseline MRD testing (using multiparameter flow cytometry, MFC) must be completed at enrollment; Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; Major organ function is basically normal and meets the following requirements: ① Liver function: total bilirubin ≤1.5×ULN (except patients with liver metastasis or Gilbert's syndrome), ALT and AST ≤2.5×ULN; ② Kidney function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min; ③ Cardiac function: left ventricular ejection fraction (LVEF) ≥50%; The patient or their legal representative signs a written informed consent form, agrees to comply with the study protocol, and completes the specified follow-up procedures.
Exclusion: Undergoing major surgery, radiation therapy, other chemotherapy drugs, or investigational drug treatments within 3 weeks prior to study drug treatment; Presence of other active malignant tumors (excluding indolent tumors that have been cured, such as basal cell carcinoma of the skin and carcinoma in situ of the cervix); Existence of uncontrolled severe infection (such as sepsis, fungal pneumonia, active tuberculosis, etc.); History of severe heart disease, including but not limited to: severe arrhythmias (such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate, etc.), history of myocardial infarction (within the past 6 months), severe heart failure (NYHA functional class ≥3), etc; Known allergy to venetoclax, cytarabine, or other components of the combination regimen in the study; Having mental illness (such as schizophrenia, major depressive disorder, etc.) or cognitive dysfunction that prevents cooperation with study follow-up and treatment; Active hepatitis B virus infection (HBV DNA positive), active hepatitis C virus infection (HCV RNA positive), or human immunodeficiency virus (HIV) infection; Central nervous system leukemia; Women who are pregnant or breastfeeding; women planning pregnancy or men of reproductive potential who have not used effective contraception during the study and within 6 months after treatment.