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Acalabrutinib for Mantle Cell Lymphoma
Study Summary
This trial studies the effects of acalabrutinib on patients with mantle cell lymphoma who cannot tolerate ibrutinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT04346199Trial Design
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Media Library
- I have experienced severe side effects from treatment.I have a heart condition.My blood counts meet the required levels despite having MCL in my bone marrow.I have had severe low white blood cell counts with fever or infection.My kidneys work well enough (Cr clearance over 30 mL/min).I need treatment for my condition now, not just monitoring.My blood pressure is not well-controlled.I have a tumor that can be measured and is larger than 1.5 cm.I am taking more than 10 mg of prednisone or its equivalent daily.I have not had a heart attack in the last 6 months.My lymphoma is CD20 positive with specific genetic features.I am cancer-free except for minor skin cancers or cancers in remission with a life expectancy over 3 years.You have read and agreed to sign a form that explains the study and your participation in it, approved by the Institutional Review Board.My liver function tests are within the required range.I am using or willing to use effective birth control during and after treatment.My heart condition severely limits my daily activities.I was not initially given ibrutinib due to concerns about my other health issues but have now been cleared by a cardiologist.I need medication for stomach acid, like omeprazole.I have had hepatitis B vaccination or natural immunity, and if I have hepatitis C, it is not active.My heart rate is often below 50 beats per minute.I have experienced severe side effects from treatment.I have low blood pressure.I haven't had any recent bleeding disorders or strokes.You have a serious medical condition, such as uncontrolled diabetes, COPD, or kidney problems, that the doctor believes could make participating in the study too risky. You also have a psychiatric illness or difficult social circumstances that could make it hard for you to follow the study's rules or sign the consent form.I have not progressed or had an allergic reaction while on ibrutinib therapy.I have uncontrolled AIHA or ITP.I have not had major surgery in the last 4 weeks.I do not have any major stomach or bowel problems that could affect medication absorption.I haven't taken antibiotics or antivirals in the last 14 days.My treatment was stopped due to severe blood-related side effects, not cancer progression.I have active heart disease symptoms.I have been treated with acalabrutinib before.I can do most of my daily activities on my own.I need medication that strongly affects liver enzymes.I have side effects from previous ibrutinib treatment, but not blood-related issues.My white blood cell and platelet counts meet the study's requirements despite my bone marrow condition.Your absolute neutrophil count (ANC) should be higher than 1000 cells per cubic millimeter.I have been diagnosed with sick sinus syndrome.I stopped taking ibrutinib for reasons other than my cancer getting worse.I cannot tolerate Ibrutinib due to severe side effects despite receiving care.I have experienced rapid heartbeats originating from my ventricles.I have two or more serious side effects not related to my blood.My treatment was stopped due to severe blood-related side effects, not because my condition worsened.My cancer has mutations making it resistant to certain treatments.I do not have brain involvement with my lymphoma or a condition called PML.I need to take warfarin or a similar medication to prevent blood clots.Any side effects I had from previous treatments are mild now.I often feel dizzy or faint.I have ongoing and uncontrolled irregular heartbeats.
- Group 1: Treatment (acalabrutinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is enrollment still available for this examination?
"Clinicaltrials.gov has this trial listed as actively recruiting, with the initial study post on August 7th 2020 and the most recent update occurring August 22nd 2022."
Has Acalabrutinib attained official sanction from the FDA?
"Due to a lack of evidence in regards to efficacy, Acalabrutinib's safety is tentatively rated as 2 on the 1-3 scale. However, there have been findings that indicate it may be safe for use."
What medical conditions has Acalabrutinib been known to treat effectively?
"Acalabrutinib is used to treat a variety of illnesses, including chronic lymphocytic leukemia (CLL), renal dysfunction, kidney failure and mantle cell lymphoma (MCL)."
Are there any additional exploratory studies that have been undertaken with Acalabrutinib?
"Presently, 107 clinical studies are in progress concerning Acalabrutinib. Out of these trials, 14 have advanced to Phase 3 and the majority is being conducted from locations in Boston, Massachusetts. Across 8882 medical centres worldwide, research into this treatment continues."
Is this study pioneering a new area of medical research?
"Acalabrutinib has been under clinical investigation since 2007, when the initial study was sponsored by Baxter Healthcare Corporation. Upon completion of this 4640-subject trial in 2007, Acalabrutinib obtained its Phase 4 drug approval. Currently there are 107 active studies being conducted across 1220 cities and 49 nations worldwide."
What is the current recruitment rate for this trial?
"Affirmative. The clinicaltrials.gov database reveals that this medical research is still actively recruiting patients, with an original post date of August 7th 2020 and a recent update on August 22nd 2022. This study requires 30 participants from one clinic for full completion."
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