Using venetoclax and azacitidine for young patients with newly diagnosed acute myeloid leukemia
A Phase II Study to Evaluate the Safety and Efficacy of Venetoclax in Combination With Azacitidine and CAG(VA-CAG) as Induction Therapy in Newly Diagnosed Patients With Acute Myeloid Leukemia(AML)
This study is testing a new treatment combining venetoclax and azacitidine for young adults with newly diagnosed acute myeloid leukemia to see if it works better than standard options, especially for those who can’t have intensive chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hematology department of the 920th hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT05662956 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a treatment regimen combining venetoclax with azacitidine and CAG (G-CSF, low dose cytarabine, and aclarubicin) for young adults aged 18 to 65 who have recently been diagnosed with acute myeloid leukemia (AML). The study is open-label and multicenter, aiming to enroll approximately 100 participants. The goal is to determine how well this combination therapy works compared to standard treatments, particularly for patients who are not candidates for intensive chemotherapy. Previous studies have indicated that this combination may lead to high remission rates and good tolerance in older patients, prompting this investigation in a younger demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been newly diagnosed with acute myeloid leukemia and have not received prior therapy.
Not a fit: Patients with acute promyelocytic leukemia or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective induction therapy option for young patients with newly diagnosed AML.
How similar studies have performed: Previous studies have shown promising results with similar treatment combinations in older AML patients, suggesting potential success for this approach in younger patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥ 18 years old and ≤ 65 years old 2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification; 3. Patients without receiving prior therapy for AML; 4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3; 5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN 6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN 7. Heart function: left ventricular ejection fraction ≧45% 8. Patients must participate in this clinical trial voluntarily and sign an informed consent form. Exclusion Criteria: 1. Acute promyeloid leukemia； 2. AML with central nervous system (CNS) infiltration； 3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML； 4. Patients with a life expectancy \<3 months 5. Patients with uncontrolled active infection; 6. HIV infection; 7. 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. 8. Female who are pregnant, breast feeding or childbearing potential. 9. Patients deemed unsuitable for enrollment by the investigator.
Where this trial is running
Kunming, Yunnan
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China — Kunming, Yunnan, China (Recruiting)
Study contacts
- Principal investigator: Sanbin Wang, MD — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Study coordinator: Sanbin Wang, MD
- Email: Wangsanbin2022@126.com
- Phone: 13187424131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.