Clinical trial · Interventional
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
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
NCT06928376CI-TRIAL-00110940recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| First Line Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "3+7" | Drug | — | UNRESOLVED |
| Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Venetoclax Combined With CACAG Regimen
- description
- The CACAG+Venetoclax regimen has a total treatment period of 1 week, with a treatment cycle every 4 weeks, and a total of 1 course of treatment. Chidamide: 30 mg, twice a week, for a total of 2 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, continued until neutrophil recovery and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, when used in combination with azole drugs, the dosage is reduced to 100 mg/day.
- interventionNames
- Drug: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
- type
- ACTIVE_COMPARATOR
- label
- "3+7" Regimen
- description
- Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.) \-
References
Publications (0)
Data not yet available
No reference posted for this study.