Tests a drug combination for adults newly diagnosed with acute myeloid leukemia
Tests venetoclax with azacitidine, cytarabine, idarubicin and G-CSF in newly diagnosed leukemia.
Plain-language title generated from the registry record
Registry title: VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
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 with newly diagnosed acute myeloid leukemia (AML) who are fit enough for intensive chemotherapy and have had no AML treatment yet.
- Age
- 18 to 70 years.
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia (not acute promyelocytic leukemia), confirmed by tests under the WHO 2022 criteria. Must be judged able to handle intensive chemotherapy. ECOG performance status of 2 or lower. Expected survival of more than 3 months.
- Earlier treatment
- No earlier AML treatment. Hydroxyurea or similar agents used to control blast cells in the blood during diagnosis are allowed. No earlier venetoclax or azacitidine for other diseases.
Main reasons for not taking part
- History of myeloproliferative neoplasms, CML, or AML with BCR-ABL1 translocation
- Other cancer within the past 2 years, with a few exceptions
- Uncontrolled severe infection or active bleeding
- Leukemia in the central nervous system before treatment
- Pregnant or breastfeeding women
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 70 years old?
Source: NCT07514832, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaTaking people
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
- Beijing 302 Hospital
- Trial code
- NCT07514832
- Record updated
- 7 April 2026
- Original description
This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor [G-CSF]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.Read full original descriptionShow less
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
This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor [G-CSF]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.
Inclusion: Diagnosis of acute myeloid leukemia (AML, excluding acute promyelocytic leukemia) confirmed by morphology, immunophenotyping and molecular genetics, in accordance with the WHO 2022 diagnostic criteria for AML; Age 18-70 years, with no gender restriction; No prior AML-related treatment has been received; exceptions are made for the use of hydroxyurea or similar agents during the diagnostic screening phase to control peripheral blood leukemic blasts; Patients must be assessed as tolerable to intensive chemotherapy regimens; evaluation of tolerance to intensive chemotherapy shall be performed in accordance with the Ferrara 2013 criteria (Appendix A); Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2; Serum creatinine ≤ 2.0 × upper limit of normal (ULN), or creatinine clearance > 40 mL/min calculated by the Cockcroft-Gault formula for glomerular filtration rate (GFR); Total bilirubin ≤ 2 × ULN, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN; Left ventricular ejection fraction (LVEF) ≥ 45%, or LVEF measured by echocardiography (ECHO) within the normal range; Expected survival > 3 months.
Exclusion: Patients with a prior history of venetoclax or azacitidine (Aza) treatment for other diseases; History of other concurrent malignancies within 2 years prior to enrollment, except:; Adequately treated carcinoma in situ of the cervix or breast; Basal cell carcinoma or localized squamous cell carcinoma of the skin; Previously controlled malignancies treated with radical surgical resection (or other curative modalities), etc; Women of childbearing potential who do not agree to use at least one reliable contraceptive method from Day 1 of the study until 90 days after the last dose of study medication; sexually active male subjects who do not agree to use contraceptive measures from Day 1 of the study until 90 days after the last dose of study medication; male subjects who do not agree to refrain from sperm donation from the start of study drug administration until at least 90 days after the last dose; Subjects with a history of myeloproliferative neoplasms (MPNs), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and acute myeloid leukemia (AML) with BCR-ABL1 translocation; Known hypersensitivity to any component of the investigational medicinal products; Presence of uncontrolled severe infection or active bleeding; Subjects with active, treatment-uncontrolled viral infection caused by HIV, hepatitis B virus, or hepatitis C virus; Subjects with epilepsy requiring pharmacotherapy, dementia, or other abnormal psychiatric conditions that impair the ability to understand or comply with the study protocol; Presence of psychiatric disorders or cognitive impairment that prevents cooperation with treatment and follow-up; conditions limiting oral drug intake or gastrointestinal absorption; Pregnant or lactating women; Subjects with evidence of central nervous system leukemia before treatment initiation.