drugset / Trial / NCT07514936
Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
Phase 2
Recruiting
120 enrolled
Chinese PLA General Hospital
940 Hospital of the People's Liberation Army Joint Logistic Support Force · collab960th Hospital of Joint Logistics Support Force of People's Liberation Army of China · collabFirst Affiliated Hospital of Harbin Medical University · collabThe General Hospital of Western Theater Command · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
Timeline
- Start
- 2024-11-18
- Primary completion
- 2027-09-30
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclacinomycin | Unknown | 20 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | — |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | — |
| Comparator | Idarubicin | Small molecule | 8 mg/m2 | — |
| Comparator | Idarubicin | Small molecule | 12 mg/m2 | — |
| Comparator | Mitoxantrone | Small molecule | 6 mg/m2 | — |
| Comparator | Mitoxantrone | Small molecule | 10 mg/m2 | — |
| Subject | Tucidinostat | Small molecule | 30 mg | — |
| Subject | Venetoclax | Small molecule | 100 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Background | filgrastim | Protein / enzyme biologic | 300 ug | — |