AU2 for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJennifer R Brown, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jennifer R. Brown, MD, PhD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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)

Research Team

Jennifer R Brown, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with Chronic Lymphocytic Leukemia (CLL) who either have relapsed after treatment or haven't been treated before. Participants should be in relatively good health, able to take oral medication, and willing to use effective contraception. Those with more than two prior cancer treatments, recent major surgery, certain blood disorders, active infections like Hepatitis B/C or HIV are excluded.

Inclusion Criteria

My disease has not been treated before.

My heart function is classified as class 2B or better.

I have CLL that has come back or didn't respond to treatment, and I've had 2 or fewer prior treatments.

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Exclusion Criteria

Allergic reactions attributed to study drugs or compounds of similar chemical or biologic composition

I am not taking strong drugs that affect liver enzyme CYP3A4.

I do not have active Hepatitis B or C, cytomegalovirus, or HIV.

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Treatment Details

Interventions

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Ublituximab (Monoclonal Antibody)
Umbralisib (Phosphoinositide 3-Kinase (PI3K) Inhibitor)

Trial OverviewThe study tests a combination of three drugs: Acalabrutinib (CALQUENCE®), Umbralisib (TGR-1202), and Ublituximab (TG-1101). It aims to determine their effectiveness in treating CLL when used together. The trial includes people who have had previous treatments as well as those who are untreated.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2-Treatment NaiveExperimental Treatment3 Interventions

Participants with previously untreated disease * Treatment with Acalabrutinib \& Umbralisib beginning C1D1, * Ublituximab beginning C7D1 * Assessment of treatment response * Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years

Group II: Cohort 1-Relapsed DiseaseExperimental Treatment3 Interventions

Participants with relapsed disease * Treatment with Acalabrutinib \& Umbralisib beginning C1D1, * Ublituximab beginning C7D1 * Assessment of treatment response * Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: