Actively Recruiting
A Multicenter, Prospective, Single-Arm Clinical Trial of Venetoclax in Combination With Azacitidine, Cytarabine, Idarubicin and G-CSF (VA-CIG) for Patients With Previously Untreated Acute Myeloid Leukemia
Led by Beijing 302 Hospital · Updated on 2026-04-07
48
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the VA-CIG regimen, which combines venetoclax, azacitidine, idarubicin, low-dose cytarabine, and granulocyte colony-stimulating factor (G-CSF), as an induction therapy for patients with previously untreated acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This is a multicenter, prospective, single-arm Phase 2 clinical trial designed to assess the safety and effectiveness of this combination treatment in adults aged 18 to 70 years with fit AML. Participants receive the VA-CIG chemotherapy regimen, which includes venetoclax taken orally with a dose escalation over the first days, azacitidine given as a subcutaneous injection for seven days, cytarabine and idarubicin administered intravenously over several days, and G-CSF injected subcutaneously from the day before treatment until white blood cell counts reach a specified level. Each treatment cycle lasts 28 days, and patients are monitored throughout the therapy. During the study, participants will undergo regular assessments including evaluation of treatment response after the first 28-day cycle, with measures such as the combined complete response rate and minimal residual disease remission. Safety is monitored closely from treatment start until two weeks after therapy ends. Other evaluations include blood tests, heart function measurements, and performance status assessments to ensure participants tolerate the intensive regimen. The study participation period extends up to the end of treatment and follow-up assessments.
CONDITIONS
Brief Title
VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, confirmed by morphology, immunophenotyping and molecular genetics according to WHO 2022 criteria
- Age between 18 and 70 years, any gender
- No prior AML-related treatment except hydroxyurea or similar agents during diagnostic screening
- Able to tolerate intensive chemotherapy as assessed by Ferrara 2013 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- Serum creatinine less than or equal to 2.0 times the upper limit of normal or creatinine clearance above 40 mL/min
- Total bilirubin less than or equal to 2 times upper limit of normal, AST or ALT less than or equal to 3 times upper limit of normal
- Left ventricular ejection fraction (LVEF) 45% or higher or normal by echocardiography
- Expected survival longer than 3 months
You will not qualify if you...
- History of myeloproliferative neoplasms including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation
- Prior treatment with venetoclax or azacitidine for other diseases
- Known allergy to any study drug components
- Other active malignancies within 2 years except certain treated skin or cervical cancers
- Uncontrolled severe infection or active bleeding
- Pregnant or breastfeeding women
- Active viral infections with HIV, hepatitis B or C not under control
- Evidence of central nervous system leukemia before treatment
- Women of childbearing potential or sexually active men not agreeing to use reliable contraception during and after the study
- Epilepsy requiring medication, dementia, or psychiatric conditions preventing study participation
- Psychiatric or cognitive impairment limiting cooperation or oral drug intake or gastrointestinal absorption issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants are treated with the VA-CIG chemotherapy regimen which includes Venetoclax, Azacitidine, Cytarabine, Idarubicin, and G-CSF over 28-day cycles.
Visits occur throughout each 28-day treatment cycle
Duration - Up to 2 weeks after end of treatment
Participants are monitored for adverse events for up to 2 weeks after treatment ends.
1 to 2 visits during follow-up period
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Dr. Gao Xiaoning, Chief Physician, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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