drugset / Trial / NCT02756897
Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This phase II trial studies how well venetoclax and ibrutinib work in treating patients with chronic or small lymphocytic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may help control chronic or small lymphocytic leukemia.
Timeline
- Start
- 2016-07-07
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
Publications
- Jain N, Keating M, Thompson P, Ferrajoli A, Burger JA, Borthakur G, Takahashi K, Estrov Z, Sasaki K, Fowler N, Kadia T, Konopleva M, Alvarado Y, Yilmaz M, DiNardo C, Bose P, Ohanian M, Pemmaraju N, Jabbour E, Kanagal-Shamanna R, Patel K, Wang W, Jorgensen J, Wang SA, Garg N, Wang X, Wei C, Cruz N, Ayala A, Plunkett W, Kantarjian H, Gandhi V, Wierda WG. Ibrutinib Plus Venetoclax for First-line Treatment of Chronic Lymphocytic Leukemia: A Nonrandomized Phase 2 Trial. JAMA Oncol. 2021 Aug 1;7(8):1213-1219. doi: 10.1001/jamaoncol.2021.1649.
- Jain N, Keating M, Thompson P, Ferrajoli A, Burger J, Borthakur G, Takahashi K, Estrov Z, Fowler N, Kadia T, Konopleva M, Alvarado Y, Yilmaz M, DiNardo C, Bose P, Ohanian M, Pemmaraju N, Jabbour E, Sasaki K, Kanagal-Shamanna R, Patel K, Jorgensen J, Garg N, Wang X, Sondermann K, Cruz N, Wei C, Ayala A, Plunkett W, Kantarjian H, Gandhi V, Wierda W. Ibrutinib and Venetoclax for First-Line Treatment of CLL. N Engl J Med. 2019 May 30;380(22):2095-2103. doi: 10.1056/NEJMoa1900574.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |