CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 29 enrolled
Drug / intervention
Acalabrutinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04624633
NCT04624633Phase 2Active
CompareCT.gov

A Phase 2 Study of Acalabrutinib, Umbralisib, and Ublituximab (AU2) in Relapsed and Previously Untreated CLL Patients

Jennifer R. Brown, MD, PhD·interventional·Posted Nov 12, 2020·Updated Feb 25, 2026

In Brief

A Phase 2 clinical trial evaluating Acalabrutinib, Umbralisib, and 1 other intervention for Chronic Lymphocytic Leukemia and 3 related conditions. Active but no longer recruiting, targeting 29 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
CountriesUnited States
CollaboratorsAstraZeneca, TG Therapeutics, Inc.

Timeline

Phase 2Active
20212022202320242025202620272028
First PostedNov 12, 2020
Enrollment StartDec 15, 2020
Primary CompletionDec 21, 2023
Study CompletionJan 1, 2028
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.6 years ago

Interventions

Acalabrutinibdrug

Oral, twice a day, predetermined dosage

Umbralisibdrug

Oral, once a day, predetermined dosage, each 28 day cycle up to 24 cycles

Ublituximabdrug

28 day cycle, starting cycle 7 via iv, on at predetermined dosage and timepoints in each cycle