Actively Recruiting
VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial
Led by Beijing 302 Hospital · Updated on 2026-04-07
48
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Diagnosed with acute myeloid leukemia (AML) confirmed by WHO 2022 criteria, excluding acute promyelocytic leukemia
- Aged between 18 and 70 years with no gender restriction
- No prior AML treatment except hydroxyurea or similar agents during screening
- Assessed as able to tolerate intensive chemotherapy based on Ferrara 2013 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Serum creatinine less than or equal to 2.0 times the upper limit of normal or creatinine clearance greater than 40 mL/min
- Total bilirubin less than or equal to 2 times the upper limit of normal; AST or ALT less than or equal to 3 times the upper limit of normal
- Left ventricular ejection fraction (LVEF) of at least 45% or within normal range 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 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 medication components
- Other active cancers within 2 years prior to enrollment except certain treated carcinomas or skin cancers
- Uncontrolled severe infections or active bleeding
- Pregnant or lactating women
- Active, untreated viral infections such as HIV, hepatitis B or C
- Evidence of central nervous system leukemia before treatment
- Women of childbearing potential and sexually active men not agreeing to use contraception during and 90 days after treatment
- Epilepsy requiring medication, dementia, or psychiatric conditions impairing study compliance
- Psychiatric or cognitive disorders preventing cooperation or conditions limiting oral drug intake or absorption
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Dr. Gao Xiaoning, Chief Physician, Professor
CONTACT
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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