drugset / Trial / NCT06084819
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Phase 2
Recruiting
200 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 · collabAir Force Military Medical University, China · collabFirst Hospital of China Medical University · collabPeople's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center · collabThe General Hospital of Northern Theater Command · collabThe General Hospital of Western Theater Command · collabYantai Yuhuangding Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2029-01-31
- Completion
- 2030-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclacinomycin | Unknown | 20 mg | — |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Comparator | Cladribine | Small molecule | 5 unknown | — |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 150 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 1 g/kg | — |
| Subject | Cytarabine | Small molecule | 2 g/kg | — |
| Comparator | Daunorubicin | Small molecule | 45 mg/m2 | — |
| Comparator | Decitabine | Small molecule | 20 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | — |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | — |
| Comparator | HHT | Unknown | 2 mg/m2 | — |
| Comparator | Mitox | Unknown | 10 mg/m2 | — |
| Subject | Tucidinostat | Small molecule | 30 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 300 ug | — |