Treatment of newly diagnosed acute myeloid leukemia with Azacitidine and Venetoclax
To Evaluate Safety and Efficacy of Azacitidine Combination With Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients：A Multicenter, Single-arm Study
This study is testing if a combination of two medications, Azacitidine and Venetoclax, can help people with newly diagnosed acute myeloid leukemia feel better and stay in remission.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guanzhou, Guandong) |
| Trial ID | NCT05471700 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the safety and efficacy of a combination therapy using Azacitidine and Venetoclax for patients with newly diagnosed acute myeloid leukemia (AML). The study involves a single-arm approach where participants receive Azacitidine and escalating doses of Venetoclax over a 28-day treatment cycle. Patients will be monitored for response to treatment, relapse, and survival for up to two years following induction therapy. The goal is to determine the effectiveness of this regimen in inducing remission in fit AML patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 65 with untreated acute myeloid leukemia and an ECOG performance status of 0 to 3.
Not a fit: Patients with acute promyelocytic leukemia or those with active CNS involvement are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with newly diagnosed acute myeloid leukemia.
How similar studies have performed: Other studies have shown promising results with similar combinations of Azacitidine and Venetoclax in treating AML, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Age 45 to 65 years old,both male and female * 2.Be able to understand and sign informed consent * 3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia * 4.Patients with an ECOG performance status 0,1,2 or 3 * 5.Expected survival time≥3 months * 6.Laboratory indicators meet the following standards: 1. Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment 2. Serum creatinine clearance rate is greater than 30ml/min Exclusion Criteria: * 1.patients participating in other interventional or observational clinical studies currently * 2.Patients has a history of myeloproliferative neoplasm \[MPN\] * 3.Patients with acute promyelocytic leukemia * 4.Active CNS involvement in patients with acute myeloid leukemia * 5.Patients with active hepatitis B or C, HIV infection before enrollment * 6.Cardiovascular status of patients evaluate by NYHA classification method \> 2 * 7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug) * 8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration * 9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal) * 10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases: 1. Adequately treated carcinoma in situ of the cervix or carcinoma of the breast 2. Basal cell carcinoma or localized squamous cell carcinoma of skin
Where this trial is running
Guanzhou, Guandong
- Nanfang Hospital of Southern Medical University — Guanzhou, Guandong, China (Recruiting)
Study contacts
- Principal investigator: Yuhua Li, Doctor — Zhujiang Hospital
- Study coordinator: Huang Rui, Doctor
- Email: Rachelchn@163.com
- Phone: +8615918528317
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.