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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I have signs of disease that can be measured, like high lymphocyte count or large lymph nodes.
Select...
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.
Select...
I can swallow and keep down pills.
Select...
My cancer has returned or didn't respond to treatment, and I've had up to 2 prior cancer treatments.
Select...
I have signs of disease that can be measured, like high white blood cell count or large lymph nodes.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have been diagnosed with CLL or SLL according to the 2018 iwCLL criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Complete Remission after 24 Cycles
Secondary outcome measures
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 moreTrial 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
Ublituximab
2017
Completed Phase 3
~2090
Acalabrutinib
2020
Completed Phase 2
~2050
Umbralisib
2015
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Jennifer R. Brown, MD, PhDLead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,613,300 Total Patients Enrolled
TG Therapeutics, Inc.Industry Sponsor
36 Previous Clinical Trials
5,577 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong drugs that affect liver enzyme CYP3A4.My disease has not been treated before.My heart function is classified as class 2B or better.I do not have active Hepatitis B or C, cytomegalovirus, or HIV.I have CLL that has come back or didn't respond to treatment, and I've had 2 or fewer prior treatments.My condition worsened despite treatment with BTK or PI3K inhibitors.I can care for myself but may not be able to do active work.I currently have a serious infection.My disease has not been treated before.I have not had any treatment for my CLL or SLL.Your bilirubin levels cannot be higher than 1.5 times the normal limit, unless you have a condition called hemolysis or Gilbert's disease, in which case the limit is three times the normal level.I am currently taking proton pump inhibitors.My cancer has spread to my brain or spinal cord.I am currently on immunosuppressive medication, including steroids.I have signs of disease that can be measured, like high lymphocyte count or large lymph nodes.I am 18 years old or older.I haven't had major surgery in the last 28 days.I do not have uncontrolled AIHA or ITP.My CLL has transformed into large cell lymphoma.My condition requires treatment according to the latest CLL guidelines.I have been diagnosed with CLL or SLL according to the latest criteria.I can swallow and keep down pills.I have had cancer before, but it's a different type from my current diagnosis.I have had a stem cell transplant from a donor.My cancer has returned or didn't respond to treatment, and I've had up to 2 prior cancer treatments.I have signs of disease that can be measured, like high white blood cell count or large lymph nodes.I had a stem cell transplant using my own cells within the last 6 months.My organs and bone marrow are working well.I am on blood thinners like warfarin.I do not have any unmanaged ongoing illnesses.You are pregnant or currently breastfeeding.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I have irritable bowel syndrome with more than 3 loose stools daily.I have not had a stroke or major brain event in the last 6 months.I have a current or past significant bleeding problem.I have a history of PML.You have a psychiatric illness or social situations that may make it difficult for you to follow the study requirements.I have a history of inflammatory bowel disease.Your liver function should be normal, and your AST and ALT levels should not exceed a certain limit. If you have a liver disease or hemolysis, a higher limit is allowed.I have been diagnosed with CLL or SLL according to the 2018 iwCLL criteria.My condition requires treatment according to the 2018 iwCLL guidelines.I can take medication to prevent certain infections.You are taking part in another study testing a new treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1-Relapsed Disease
- Group 2: Cohort 2-Treatment Naive
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this medical trial ever been conducted before?
"Research into Acalabrutinib began in 2014 when 306 participants took part in a study sponsored by Acerta Pharma BV. Following this initial trial, the drug was approved for Phase 1 & 2 testing and today there are 89 active studies being conducted across 50 nations and 553 cities worldwide."
Answered by AI
Is Acalabrutinib a viable treatment option with minimal risk?
"Given the Phase 2 status of Acalabrutinib, there is sufficient evidence to support its safety which earns it a rating of two on our scale. At this time, no clinical data exists that proves efficacy."
Answered by AI
How many volunteers are included in the experiment?
"This study is no longer enrolling participants and has been inactive since June 13th 2022. If you're seeking alternative trials, there are 1520 studies looking for patients with leukemia or lymphoid conditions as well as 89 clinical trials accepting Acalabrutinib candidates."
Answered by AI
Are there any open slots to participate in the trial yet?
"This medical trial is not actively enrolling at this time. It was first posted on December 15th 2020, and the latest update occurred on June 13th 2022. However, there are still 1,520 studies recruiting patients with leukemia or lymphoid issues and 89 trials looking for participants to test Acalabrutinib's efficacy."
Answered by AI
In what circumstances is Acalabrutinib typically prescribed?
"Acalabrutinib is widely prescribed to alleviate the symptoms of follicular lymphoma as well as mantle cell lymphoma in those who have gone through a minimum of three systemic therapies."
Answered by AI
What prior studies have been conducted utilizing Acalabrutinib?
"Currently, 89 investigations into Acalabrutinib are ongoing and 14 of those involve Phase 3 clinical trials. While Louisville Kentucky is the main base for these studies, there are 2747 sites running acalabrutinib trials worldwide."
Answered by AI
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