Clinical trial · Interventional
Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Single Arm,open Label,phase I Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
NCT05659992CI-TRIAL-00082408completedPhase 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 evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- Experimental: Venetoclax combined CACAG regimen for newly diagnosed AML. All recipients in this arm received azacytidine, cytarabine.aclamycin, chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5. Aclamycin was uesd as 10 mg/m2/day on day1,3,5). Chidamide was uesd as 30 mg/day twice per week for 2 weeks. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery.
- interventionNames
- Drug: azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 1 month after study treatment
- description
- Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are able to understand and willing to sign the informed consent form (ICF). * All patients should aged 14 to75 years,no gender limitation. * Patients who are newly diagnosed with AML. * Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; * Renal function: creatinine ≤the upper limit of normal; * Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; * The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months. * Patients without severe allergic constitution. Exclusion Criteria: * Patients with allergy or contraindication to the study drug; * Female patients who are pregnant or breast-feeding. * Patients with active infection * Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; * Patients with mental illness or other states unable to comply with the protocol; * Less than 6 weeks after surgical operation of important organs. * Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal; * The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
References
Publications (1)
- DERIVEDLiu Q, Yang J, Lv L, Zhang X, Li M, Xu L, Huang S, Jing Y, Dou L. Phase 2 study of chidamide in combination with CAG and venetoclax-azacitidine in older patients with newly diagnosed acute myeloid leukemia. Front Immunol. 2025 Feb 26;16:1525110. doi: 10.3389/fimmu.2025.1525110. eCollection 2025. PMID 40079007