Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

Phase 2 Active not recruiting 29 enrolled Jennifer R. Brown, MD, PhD AstraZeneca · collab TG Therapeutics, Inc. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is testing the effectiveness of the study drug combination of acalabrutinib, umbralisib, and ublituximab in participants with Chronic Lymphocytic leukemia (CLL). The names of the study drugs involved in this study are/is: * Acalabrutinib (CALQUENCE®, ACP-196) * Umbralisib (TGR-1202) * Ublituximab (TG-1101)

Timeline

Start: 2020-12-15
Primary completion: 2023-12-21
Completion: 2028-01-01

Publications

Yin Y, Xu H, He L, Brown JR, Mato AR, Aittokallio T, Skanland SS. Protein Profiles Predict Treatment Responses to the PI3K Inhibitor Umbralisib in Patients with Chronic Lymphocytic Leukemia. Clin Cancer Res. 2025 May 15;31(10):1943-1955. doi: 10.1158/1078-0432.CCR-24-2911.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acalabrutinib	Small molecule	—	Oral
Subject	Ublituximab	Monoclonal antibody	—	Intravenous
Subject	Umbralisib	Small molecule	—	Oral

Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

Summary

Timeline

Publications

Drugs

Indications