drugset / Trial / NCT03824483
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
Phase 2
Recruiting
230 enrolled
Memorial Sloan Kettering Cancer Center
BeOne Medicines · collabMassachusetts General Hospital · collabRoche-Genentech · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL.
Timeline
- Start
- 2019-02-22
- Primary completion
- 2027-02
- Completion
- 2027-02
Outcome
Met primary endpoint
paper BOVen was well tolerated and met its primary endpoint PMID 34826411 ↗
paper 33 (89%) of 37 previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma reaching undetectable MRD in both peripheral blood and bone marrow PMID 34826411 ↗
Publications
- Kumar A, Soumerai J, Abramson JS, Barnes JA, Caron P, Chhabra S, Chabowska M, Dogan A, Falchi L, Grieve C, Haydu JE, Johnson PC, Joseph A, Kelly HE, Labarre A, Lue JK, Martignetti R, Mi J, Moskowitz A, Owens C, Plummer S, Puccio M, Salles G, Seshan V, Simkins E, Slupe N, Zhang H, Zelenetz AD. Zanubrutinib, obinutuzumab, and venetoclax for first-line treatment of mantle cell lymphoma with a TP53 mutation. Blood. 2025 Jan 30;145(5):497-507. doi: 10.1182/blood.2024025563.
- Soumerai JD, Mato AR, Dogan A, Seshan VE, Joffe E, Flaherty K, Carter J, Hochberg E, Barnes JA, Hamilton AM, Abramson JS, Batlevi CL, Matasar MJ, Noy A, Owens CN, Palomba ML, Kumar A, Takvorian T, Ni A, Choma M, Friedman C, Chadha P, Simkins E, Ruiters J, Sechio S, Portman D, Ramos L, Nolet N, Mahajan N, Martignetti R, Mi J, Scorsune K, Lynch J, McGree B, Hughes S, Grieve C, Roeker LE, Thompson M, Johnson PC, Roshal M, Huang J, Biondo J, Wu Q, Jacob A, Abdel-Wahab O, Zelenetz AD. Zanubrutinib, obinutuzumab, and venetoclax with minimal residual disease-driven discontinuation in previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2021 Dec;8(12):e879-e890. doi: 10.1016/S2352-3026(21)00307-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Subject | Zanubrutinib | Small molecule | 160 mg | Oral |