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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Venetoclax for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Mazyar Shadman
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Night sweats for > 1 month without evidence of infection
Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A line of therapy is defined as completing at least 2 cycles of treatment of standard regimen according to current National Comprehensive Cancer Network (NCCN) guidelines, or of an investigational regimen on a clinical trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining acalabrutinib with venetoclax to see if it's more effective than either drug alone in treating patients with leukemia or lymphoma that has resisted or returned after treatment.
Who is the study for?
Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma that's resistant to treatment or has returned. They must have had night sweats for over a month, relapsed after at least one therapy, and meet specific health criteria like certain blood cell counts and organ function tests. Pregnant women, those with other active cancers, significant heart issues, absorption problems, recent major surgeries, or infections like hepatitis B/C or HIV cannot join.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Acalabrutinib and Venetoclax in patients whose chronic lymphocytic leukemia or small lymphocytic lymphoma hasn't responded to previous treatments. The goal is to see if this drug combo can better halt cancer growth by blocking enzymes needed for cell growth and killing cancer cells.See study design
What are the potential side effects?
Potential side effects include increased risk of infection due to low white blood cell count; nausea; fatigue; diarrhea; muscle and joint pain; headache; fever. Some may experience liver enzyme changes indicating liver impact. Rare but serious side effects could involve bleeding problems or severe allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had night sweats for over a month without being sick.
Select...
My CLL/SLL has not improved or has returned after at least one treatment.
Select...
My spleen is very large, growing, or causing symptoms.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have had a fever over 100.5°F or 38°C for 2 weeks without signs of infection.
Select...
I have been diagnosed with CLL or SLL according to standard criteria.
Select...
My condition requires treatment according to the latest guidelines.
Select...
My blood tests show worsening anemia or low platelet counts.
Select...
My lymph nodes are very large or getting worse and causing symptoms.
Select...
I have lost more than 10% of my weight without trying in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 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 undetectable measurable residual disease (uMRD)
Secondary outcome measures
Complete response (CR)
Heart rate
Overall survival (OS)
+3 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib, venetoclax)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID and venetoclax PO QD on days 1-28. Patients receive acalabrutinib alone for the first three 28 day cycles. Venetoclax is added beginning with Cycle 4. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,315 Total Patients Enrolled
93 Trials studying Lymphoma
6,113 Patients Enrolled for Lymphoma
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,458 Total Patients Enrolled
100 Trials studying Lymphoma
6,517 Patients Enrolled for Lymphoma
AstraZenecaIndustry Sponsor
4,275 Previous Clinical Trials
288,613,566 Total Patients Enrolled
51 Trials studying Lymphoma
6,372 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with progressive multifocal leukoencephalopathy.My condition worsened while I was on venetoclax.You have had a bad reaction or could not tolerate acalabrutinib or venetoclax in the past.I have had night sweats for over a month without being sick.My CLL/SLL has not improved or has returned after at least one treatment.I experience severe tiredness.My spleen is very large, growing, or causing symptoms.I have no active cancer except for certain skin cancers, low-grade prostate cancer, or any cancer I've been free from for 2+ years.I don't have issues absorbing medication despite my history of stomach or bowel surgery.I am able to get out of my bed or chair and move around.I have HIV or a serious infection.I am not on strong drugs that affect liver enzymes.I have not had major surgery in the last 7 days or have fully recovered if I did.I do not have uncontrolled AIHA or ITP.I have not had a stroke or brain bleed in the last 6 months.I have had a fever over 100.5°F or 38°C for 2 weeks without signs of infection.I have or am suspected to have had a specific type of leukemia or a condition where my leukemia has changed into a more aggressive form.I am currently taking medication for acid reflux or heartburn.I have been diagnosed with CLL or SLL according to standard criteria.I do not have serious heart issues like recent heart attacks or uncontrolled heart rhythm problems.My white blood cell count has rapidly increased, not due to infection.My condition requires treatment according to the latest guidelines.My white blood cell count is within the required range for the trial.My condition worsened while I was on a BTK inhibitor.I am 18 years old or older.My blood tests show worsening anemia or low platelet counts.My lymph nodes are very large or getting worse and causing symptoms.I do not have a bleeding disorder nor am I on strong blood thinners like warfarin.You have had a severe allergic reaction or anaphylaxis to acalabrutinib or venetoclax in the past.I experience symptoms related to my illness.I have lost more than 10% of my weight without trying in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib, venetoclax)
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.
Is there still availability for participants in this trial?
"This study, which was first published on January 1st 2023 and last updated on September 2nd 2022, is no longer accepting patients. Nevertheless, 4011 other trials are actively enrolling at the present moment."
Answered by AI
What other investigations have been conducted regarding Acalabrutinib?
"Presently, there are 313 investigations into Acalabrutinib's efficacy and 39 of those trials are in their concluding phase. Many such experiments take place out of Toronto, Ontario; though the total number of international sites running these tests is 15754."
Answered by AI
Is Acalabrutinib a risk-free medication for users?
"Although its efficacy is yet to be demonstrated, Acalabrutinib has been deemed a safe drug with a score of 2 based on the information gathered from Phase 2 trials."
Answered by AI
What is the number of test subjects receiving treatment in this clinical experiment?
"Unfortunately, this clinical trial is no longer accepting any more participants. It was originally posted on January 1st 2023 and its last edit occurred on September 2nd 2022. If you are still searching for other studies to join, there are currently 3698 trials enrolling individuals with chronic recurrent lymphocytic leukemia and 313 trails offering Acalabrutinib treatments which have active recruitment programs."
Answered by AI
What medical conditions is Acalabrutinib typically utilized to treat?
"Acalabrutinib is highly effective at treating renal dysfunction, as well as other ailments including chronic lymphocytic leukemia (CLL), kidney failure, and mantle cell lymphoma (MCL)."
Answered by AI
Does this medical trial present an innovative approach?
"Currently, Acalabrutinib is being trialed in 313 active studies across 1666 urban areas and 51 countries. This journey began with Baxter Healthcare Corporation's Phase 4 trial of 4640 volunteers back in 2007; since then, 113 further trials have been conducted."
Answered by AI
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