drugset / Trial / NCT05048615
Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML
NaSingle-groupOpen-labelTreatment
Summary
Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy.
Timeline
- Start
- 2021-07-26
- Primary completion
- 2023-01-20
- Completion
- 2023-01-20
Publications
- Background Dohner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. No abstract available.
- Background Guerra VA, DiNardo C, Konopleva M. Venetoclax-based therapies for acute myeloid leukemia. Best Pract Res Clin Haematol. 2019 Jun;32(2):145-153. doi: 10.1016/j.beha.2019.05.008. Epub 2019 May 24.
- Background Pollyea DA, Amaya M, Strati P, Konopleva MY. Venetoclax for AML: changing the treatment paradigm. Blood Adv. 2019 Dec 23;3(24):4326-4335. doi: 10.1182/bloodadvances.2019000937.
- Background DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, Frankfurt O, Konopleva M, Wei AH, Kantarjian HM, Xu T, Hong WJ, Chyla B, Potluri J, Pollyea DA, Letai A. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25.
- De la Garza-Salazar F, Colunga-Pedraza PR, Gomez-Almaguer D, Garcia-Zarate VA, Gomez-De Leon A. Low dose venetoclax plus itraconazole outpatient induction in newly diagnosed acute myeloid leukemia: A phase 2 study. Leuk Res. 2023 Oct;133:107373. doi: 10.1016/j.leukres.2023.107373. Epub 2023 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Venetoclax | Small molecule | 100 mg | Oral |
| Background | Itraconazole | Small molecule | 100 mg | Oral |