Comparing two treatment regimens for newly diagnosed acute myeloid leukemia
Official title: 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
Run by Chinese PLA General Hospital · NCT06928376 · Data updated 2026-11-12
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 |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | April 18, 2024 |
| Main results expected | September 1, 2025 |
| Study ends | September 1, 2026 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT06928376 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using novel combinations of therapies for AML, but this specific combination is relatively novel.
Who can join: the full rules
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 it's running
-
Chinese PLA General Hospital
Beijing, Beijing Municipality, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Tailored exercise program to improve quality of life for adults with hematologic cancers
This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.
-
Characterization of CD180 Protein Expression in Myeloid Blood C cancers
This study tests how CD180 is presented on myeloid cancer cells and normal stem cells using existing patient samples from AML cases to see if it could help with diagnosis or monitoring.
-
Personalized AML: Find biomarkers to predict response to venetoclax
This study tests whether single-cell analyses can help group AML patients by biology and find biomarkers that predict who will respond to venetoclax.
-
Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia
This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.
-
MAX-40279 with Venetoclax and Azacitidine for unfit newly diagnosed AML
This study tests MAX-40279 added to venetoclax and azacitidine in older or unfit adults newly diagnosed with AML to see if it is safe and shows activity.
-
Venetoclax and Azacitidine Consolidation After Remission in Intermediate-Risk AML
We’re testing if a venetoclax-plus-azacitidine consolidation approach works as well as standard high-dose chemotherapy for adults with intermediate-risk AML who have already achieved remission and are headed to stem cell transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.