Comparing two treatment regimens for newly diagnosed acute myeloid leukemia
A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia
This study is testing a new treatment for people with newly diagnosed acute myeloid leukemia to see if it works better than the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06928376 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of a new treatment regimen combining venetoclax with CACAG against the traditional '3+7' regimen for patients with newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML). The trial will involve multiple centers and will assess how well these treatments work in improving patient outcomes. Participants will be closely monitored for their response to treatment and any potential side effects. The goal is to identify a more effective therapy for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14 to 75 who have been newly diagnosed with intermediate- or high-risk acute myeloid leukemia.
Not a fit: Patients with contraindications to the study drugs, severe organ dysfunction, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with acute myeloid leukemia, potentially improving survival rates.
How similar studies have performed: Other studies have shown promise in using novel combinations of therapies for AML, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution Exclusion Criteria: Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.) \-
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
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.