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Acalabrutinib for Chronic Lymphocytic Leukemia (ASSURE Trial)
ASSURE Trial Summary
This trial is testing a new medication, acalabrutinib, to see if it is safe and effective in treating people with chronic lymphocytic leukemia. The trial will last for approximately 72 months and will enroll 600 participants.
ASSURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowASSURE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT04346199ASSURE Trial Design
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Who is running the clinical trial?
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- I have had cancer before, but I've been cancer-free for over 2 years, except for minor skin cancers or early prostate cancer.My blood test shows a specific type of abnormal B-cells.My kidney function, measured by creatinine clearance, is below 30 mL/min.My chronic lymphocytic leukemia has spread to my brain.I have a history of or currently have interstitial lung disease.I haven't had chemotherapy, radiation, or any CLL treatment in the last 30 days.My blood tests show worsening anemia or low platelets.I have very large (over 10 cm), growing, or bothersome swollen lymph nodes.I am a woman who can have children, sexually active, and agree to use effective birth control during the study.I do not have serious heart problems or a recent heart attack.I have a bleeding disorder like hemophilia.My condition has progressed to Richter's transformation.I have not had a stroke or brain bleed in the last 6 months.Your blood lymphocytes should not have more than 55% of a certain type of cell called prolymphocytes during screening.My spleen is very large, getting bigger, or causing symptoms.I have been diagnosed with progressive multifocal leukoencephalopathy.I have a blood condition that is not under control and requires high doses of steroids.I do not have HIV, active hepatitis B or C, any uncontrolled infection, and haven't had a live vaccine in the last 4 weeks.My cancer has been tested for specific genetic changes recently.I have not had major surgery in the last 4 weeks or have fully recovered from it.My white blood cell count has significantly increased in a short period.I am not taking warfarin or similar blood thinners within 7 days before starting the study treatment.My condition worsened while I was on a BTK inhibitor treatment.My autoimmune blood condition doesn't improve with standard treatments.I am 18 years old or older.You have a high number of B lymphocytes in your blood since you were first diagnosed.You have a medical condition that meets the iwCLL 2018 criteria for active disease.I need medication for stomach acid, like omeprazole.You are currently breastfeeding or pregnant.You are already participating in another medical study.I have been diagnosed with CLL according to the 2018 Hallek criteria.I can take care of myself but might not be able to do heavy physical work.I do not have significant GI issues affecting food absorption.My white blood cell or platelet counts are low, but it's due to my CLL and can be improved with treatment.I am not on long-term strong medication that affects liver enzyme activity.
- Group 1: Acalabrutinib
- 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.
- 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
In how many different medical facilities is this research being conducted currently?
"Presently, this clinical trial is operating out of 31 different sites. Some cities with these facilities are Lincoln, Marietta and Whittier. To limit travel time commitments, you should choose the location nearest to you."
Is there a significant body of research on Acalabrutinib?
"Since 2014, when acalabrutinib was first studied at the research site, there have been 24 completed clinical trials. Currently, 76 studies are actively recruiting patients with many of these studies taking place in Lincoln, Nebraska."
What are the requirements to sign up for this test?
"This clinical trial is looking for 553 participants with leukemia or lymphoid cancer between the ages of 18 and 130. Most importantly, applicants must meet the following criteria: Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin <10 g/dL) and/or thrombocytopenia (platelets <100,000/μL). Men and women ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), Monoclonal B-cells (either kappa or lambda light chain restricted) that are"
What are the most common indications for Acalabrutinib?
"Acalabrutinib is an effective treatment for mantle cell lymphoma (mcl), small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."
Are we still able to sign up for this experiment?
"This particular trial is no longer recruiting patients. However, as of today's date, there are 1575 trials for leukemia, lymphoid and 76 studies involving Acalabrutinib that are actively looking for participants."
Does this research testing include adults over the age of 25?
"The age limit for this clinical trial is 130 years old. All patients that meet this age criteria and are over 18 years old are eligible to participate in the study."
Has the Food and Drug Administration looked favorably on Acalabrutinib?
"Given that this is a Phase 3 trial with data supporting efficacy and safety, our team has rated the safety of Acalabrutinib as a 3."
Is this a new type of clinical trial?
"Acalabrutinib has undergone 76 different clinical trials in 47 countries and 504 cities since its initial study in 2014. The first trial, which was sponsored by Acerta Pharma BV, included 306 participants and completed both Phase 1 & 2 of drug approval. In the 6 years since then, an additional 24 studies have been undertaken."
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