drugset / Trial / NCT03580928
Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL
Phase 2
Active not recruiting
72 enrolled
Dana-Farber Cancer Institute
AstraZeneca · collabGenentech, Inc. · collabNational Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab -- as a possible treatment for chronic lymphocytic leukemia (CLL). The drugs involved in this study are: * Acalabrutinib * Venetoclax * Obinutuzmab
Timeline
- Start
- 2018-08-07
- Primary completion
- 2024-04-10
- Completion
- 2027-12-31
Publications
- Davids MS, Ryan CE, Lampson BL, Ren Y, Tyekucheva S, Fernandes SM, Crombie JL, Kim AI, Weinstock M, Montegaard J, Walker HA, Greenman C, Patterson V, Jacobson CA, LaCasce AS, Armand P, Fisher DC, Lo S, Olszewski AJ, Arnason JE, Ahn IE, Brown JR. Phase II Study of Acalabrutinib, Venetoclax, and Obinutuzumab in a Treatment-Naive Chronic Lymphocytic Leukemia Population Enriched for High-Risk Disease. J Clin Oncol. 2025 Mar;43(7):788-799. doi: 10.1200/JCO-24-02503. Epub 2024 Dec 7.
- Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | 100 mg | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |