Venetoclax plus CACAG versus 3+7 for acute monocytic leukemia
Official title: Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study
Run by Chinese PLA General Hospital · NCT07512700 · Data updated 2026-11-12
This trial will test whether adding venetoclax to a CACAG combination works better than standard 3+7 chemotherapy for people aged 14–60 with acute monocytic leukemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years to 60 Years |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Beijing and 2 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | October 31, 2029 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT07512700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 14–60 with newly diagnosed acute monocytic leukemia per the 2016 WHO criteria (excluding APL), who can give informed consent, have ECOG 0–3, adequate liver and kidney function, and no uncontrolled infection or pregnancy.
✕Probably not a fit
Patients unlikely to benefit include those with acute promyelocytic leukemia, active uncontrolled infection, significant organ dysfunction, pregnancy/lactation, or known hypersensitivity to study drugs.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized Phase II trial in Beijing that will enroll 204 participants aged 14–60 with acute monocytic leukemia and randomly assign them to either venetoclax combined with the CACAG backbone (azacitidine, cytarabine, aclarubicin, chidamide and G-CSF) or to standard 3+7 induction with daunorubicin and cytarabine. Treatment consists of two cycles over about 8–10 weeks, with participants who do not achieve at least a partial response after the first cycle potentially withdrawn for alternative therapy. Key outcomes include response rates, safety/tolerability, and overall clinical outcomes during the study period. The trial compares a modern targeted-agent combination against the historical standard induction regimen to see if the new approach improves remission and safety profiles.
Why it matters
Potential benefit: If successful, the venetoclax plus CACAG approach could produce higher remission rates or a more favorable safety profile than standard 3+7 induction for acute monocytic leukemia.
How similar studies have gone: Venetoclax combined with hypomethylating agents and other backbones has shown promising response rates in AML overall, but evidence specifically in acute monocytic leukemia is more limited and results have been mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures. * Age 14 to 60 years at screening, no gender restriction. * Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia. * No history of severe allergic reactions. * Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN. * Renal function: serum creatinine ≤ 1.5 × ULN * No uncontrolled infection or severe psychiatric disorder. * ECOG performance status 0-3; life expectancy ≥ 4 months. Exclusion Criteria: * Known hypersensitivity or contraindication to any study drug. * Pregnancy or lactation. * Active infection. * Long-term smoking or alcohol abuse that may interfere with study outcome evaluation. * Psychiatric illness or other condition that prevents informed consent or compliance with study procedures. * Major organ surgery within 6 weeks prior to enrollment. * Abnormal liver function: total bilirubin \> 2× ULN, ALT/AST \> 2.5 × ULN; abnormal renal function: serum creatinine \> 1.5 × ULN. * Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).
Where it's running
-
Air Force Medical Center, PLA
Beijing, China Recruiting -
Chinese PLA General Hospital
Beijing, China Recruiting -
PLA Strategic Support Force's Characteristic Medical Center
Beijing, China Recruiting
Study contacts
- Principal investigator: Liping Dou, Doctor — Chinese PLA General Hospital
- Study coordinator: Liping Dou, Doctor
- Email: lipingruirui@163.com
- Phone: +8613681207138
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Testing STX-0712 in patients with advanced blood cancers
This study is testing a new drug called STX-0712 to see if it can help people with advanced blood cancers like chronic myelomonocytic leukemia and acute myeloid leukemia who have run out of other treatment options.
-
Treatment for newly diagnosed monocytic acute myeloid leukemia using a combination of venetoclax and chemotherapy
This study is testing a new treatment combining venetoclax and chemotherapy to see if it helps people with newly diagnosed monocytic acute myeloid leukemia feel better and live longer.
-
Combination treatment for newly diagnosed acute monocytic leukemia
This study is testing a new combination treatment for people with newly diagnosed acute monocytic leukemia who can't have intensive chemotherapy to see if it helps them feel better and manage their condition.
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.