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Bruton's Tyrosine Kinase (BTK) Inhibitor

AU2 for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Jennifer R Brown, MD, PhD

Research Sponsored by Jennifer R. Brown, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 2: Previously untreated disease

For enrollment to Cohort 1: Participants must have relapsed or refractory disease as per iwCLL 2018 criteria,1 and must have received no more than 2 prior lines of anti-cancer therapy.

Must not have

Concomitant treatment with strong inhibitors or inducers of CYP3A4

Chronic active Hepatitis B, Hepatitis C, active cytomegalovirus, or known history of HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not the combination of these three drugs is effective in treating CLL.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include diarrhea, headache, fever, fatigue, muscle pain, bruising or bleeding easily due to low blood platelets; high blood pressure; rash; irregular heartbeat; infections due to low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease has not been treated before.

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

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I can care for myself but may not be able to do active work.

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My disease has not been treated before.

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I have not had any treatment for my CLL or SLL.

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I have signs of disease that can be measured, like high lymphocyte count or large lymph nodes.

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I am 18 years old or older.

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My condition requires treatment according to the latest CLL guidelines.

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I have been diagnosed with CLL or SLL according to the latest criteria.

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I can swallow and keep down pills.

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My cancer has returned or didn't respond to treatment, and I've had up to 2 prior cancer treatments.

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I have signs of disease that can be measured, like high white blood cell count or large lymph nodes.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have been diagnosed with CLL or SLL according to the 2018 iwCLL criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My condition worsened despite treatment with BTK or PI3K inhibitors.

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I currently have a serious infection.

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I am currently taking proton pump inhibitors.

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My cancer has spread to my brain or spinal cord.

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I am currently on immunosuppressive medication, including steroids.

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I haven't had major surgery in the last 28 days.

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I do not have uncontrolled AIHA or ITP.

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My CLL has transformed into large cell lymphoma.

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I have had a stem cell transplant from a donor.

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I had a stem cell transplant using my own cells within the last 6 months.

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I am on blood thinners like warfarin.

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I do not have any unmanaged ongoing illnesses.

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I have irritable bowel syndrome with more than 3 loose stools daily.

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I have a current or past significant bleeding problem.

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I have a history of PML.

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I have a history of inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Complete Remission after 24 Cycles

Secondary study objectives

Correlation between undetectable MRD in the peripheral blood and bone marrow

Median Progression Free Survival at 2 Years

Median Progression Free Survival at 3 Years

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2110

Umbralisib

2015

Completed Phase 2

~60