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

NCT04624633 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-02-25

Study results available
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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)

Conditions

Interventions

DRUG

Acalabrutinib

Oral, twice a day, predetermined dosage

DRUG

Umbralisib

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

DRUG

Ublituximab

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • TG Therapeutics, Inc.

    collaborator INDUSTRY

  • Jennifer R. Brown, MD, PhD

    lead OTHER

Principal Investigators

  • Jennifer R Brown, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-12-21
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624633 on ClinicalTrials.gov