drugset / Trial / NCT05177731
Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML
RandomizedParallel-groupOpen-labelTreatment
Summary
This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia. This study involves the following: Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)
Timeline
- Start
- 2022-03-01
- Primary completion
- 2024-02-28
- Completion
- 2024-12-31
Publications
- Lu J, Xue SL, Wang Y, He XF, Hu XH, Miao M, Zhang Y, Tang ZX, Xie JD, Yang XF, Xu MZ, Shen YY, Du F, Wu Q, Xue MX, Wang Y, Deng AL, Dou XQ, Xu Y, Dai HP, Wu DP, Chen SN. Venetoclax and decitabine vs intensive chemotherapy as induction for young patients with newly diagnosed AML. Blood. 2025 May 29;145(22):2645-2655. doi: 10.1182/blood.2024027217.
- Waclawiczek A, Leppa AM, Renders S, Stumpf K, Reyneri C, Betz B, Janssen M, Shahswar R, Donato E, Karpova D, Thiel V, Unglaub JM, Grabowski S, Gryzik S, Vierbaum L, Schlenk RF, Rollig C, Hundemer M, Pabst C, Heuser M, Raffel S, Muller-Tidow C, Sauer T, Trumpp A. Combinatorial BCL2 Family Expression in Acute Myeloid Leukemia Stem Cells Predicts Clinical Response to Azacitidine/Venetoclax. Cancer Discov. 2023 Jun 2;13(6):1408-1427. doi: 10.1158/2159-8290.CD-22-0939.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Decitabine | Small molecule | — | Intravenous |
| Subject | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | Gilteritinib | Small molecule | — | Oral |