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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib vs Standard Therapy for Chronic Lymphocytic Leukemia
Phase 3
Waitlist Available
Research Sponsored by Acerta Pharma BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment
Must have received ≥ 1 prior systemic therapies for CLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up irc assessments from randomization date until disease progression or death or irc discontinuation on 15jan2019 (as ia per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Awards & highlights
Study Summary
This trial will compare the effectiveness of acalabrutinib to rituximab + idelalisib or bendamustine in people who have already been treated for CLL.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia (CLL) who have had at least one prior treatment. Participants must have a certain level of physical fitness (ECOG 0-2), not be pregnant or breastfeeding, agree to use effective contraception, and meet specific blood disease criteria without severe other health issues like heart disease or uncontrolled infections.Check my eligibility
What is being tested?
The study compares the effectiveness of acalabrutinib against two combinations: rituximab with idelalisib or bendamustine in people with previously treated CLL. It aims to determine which treatment works better for managing this type of leukemia.See study design
What are the potential side effects?
Potential side effects include nausea, diarrhea, fatigue, muscle and bone pain from acalabrutinib; infusion reactions from rituximab; liver problems from idelalisib; and low blood counts leading to infection risk from bendamustine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition requires treatment according to specific leukemia criteria.
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I have had at least one treatment for chronic lymphocytic leukemia.
Select...
I agree not to donate sperm during the trial.
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I have been diagnosed with CLL according to specific criteria.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I am a man who can father children and agree to use effective birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ irc assessments from randomization date until disease progression or death or irc discontinuation on 15jan2019 (as ia per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~irc assessments from randomization date until disease progression or death or irc discontinuation on 15jan2019 (as ia per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Secondary outcome measures
Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.
Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff
IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Acalabrutinib (ACP-196)Experimental Treatment1 Intervention
Acalabrutinib (ACP-196) Monotherapy
Group II: Rituximab Plus Idelalisib or BendamustineActive Control3 Interventions
Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine
Find a Location
Who is running the clinical trial?
Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,615 Total Patients Enrolled
Acerta Clinical TrialsStudy Director1-888-292-9613; acertamc@dlss.com
17 Previous Clinical Trials
2,116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My blood test shows a specific type of abnormal B-cells.I have or am suspected to have Richter's syndrome or prolymphocytic leukemia.I have not had previous treatments with radio- or toxin-conjugated antibodies.I am on blood thinners like warfarin.My condition requires treatment according to specific leukemia criteria.I have had at least one treatment for chronic lymphocytic leukemia.I agree not to donate sperm during the trial.You have a high level of B lymphocytes in your blood since your diagnosis.I haven't had cancer treatment or experimental drugs in the last 30 days.I haven't taken more than 20 mg of steroids daily in the week before starting the study drug.I have HIV or another serious infection that is not under control.I have liver damage due to medication, alcohol, or fatty liver disease.I have been diagnosed with progressive multifocal leukoencephalopathy.I have been treated with a BCL-2 or BCR inhibitor before.I have had or currently have lung inflammation caused by a drug.I have not had a stroke or brain bleed in the last 6 months.I need medication that strongly affects liver enzymes.I am 18 years old or older.My leukemia tests positive for CD20.A certain type of white blood cell called prolymphocytes can't make up more than 55% of your blood lymphocytes.I can care for myself and am up and about more than 50% of my waking hours.I have been diagnosed with CLL according to specific criteria.I have not had a live virus vaccine in the last 28 days.I can take care of myself and am up and about more than half of the day.I have not had major surgery within the last 30 days.I have a condition that affects how my body absorbs nutrients.I am a man who can father children and agree to use effective birth control.I have had cancer before, but it was a specific type allowed in this trial.I have a history of unusual bleeding.I have been diagnosed with CNS lymphoma or leukemia.I have a serious heart condition.I had a stem cell transplant less than 6 months ago.I need medication for stomach acid.I do not have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib (ACP-196)
- Group 2: Rituximab Plus Idelalisib or Bendamustine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are there any current openings for study participants?
"This study is no longer looking for new participants. The clinical trial was originally posted on February 2nd, 2017 and ended on June 2nd, 2022. However, there are 1575 other studies currently enrolling patients with chronic lymphocytic leukemia (CLL) and 521 trials for Acalabrutinib (ACP-196)."
Answered by AI
What patients does Acalabrutinib (ACP-196) usually help?
"Acalabrutinib (ACP-196) is most frequently used to diffuse large b-cell lymphoma (dlbcl), but it can also treat hodgkin disease, chronic lymphocytic leukemia, and other types of b-cell lymphomas."
Answered by AI
What are some possible adverse effects of Acalabrutinib (ACP-196)?
"Acalabrutinib (ACP-196) has received a score of 3 for safety. Phase 3 trials have some data to support efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
To what extent is this study populated?
"Unfortunately, this particular study is not seeking any more participants at the moment. Although, it's important to note that the last update was on June 2nd, 2022. There are presently 1575 trials actively searching for patients with chronic lymphocytic leukemia (cll) and 521 trials for Acalabrutinib (ACP-196)."
Answered by AI
Can you please provide a list of other times Acalabrutinib (ACP-196) has been studied in a clinical setting?
"Acalabrutinib (ACP-196) was first studied 27 years ago at National Institutes of Health Clinical Center. Out of the 911 completed clinical trials, 521 are still ongoing with a large concentration in Round Rock, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
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