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Acalabrutinib for Autoimmune Hemolytic Anemia in Chronic Lymphocytic Leukemia
Study Summary
This trial tests the effect of acalabrutinib on patients with autoimmune hemolytic anemia who have relapsed or who haven't responded to previous treatment. Acalabrutinib may stop cancer cell growth by blocking some of the enzymes needed for cell growth.
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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Who is running the clinical trial?
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- I haven't had radio- or toxin-immunoconjugate therapy in the last 10 weeks.I cannot swallow pills or have a stomach condition that affects medication absorption.I have anemia or need treatment to keep my hemoglobin above 10 g/dL.My diagnosis of CLL or SLL is confirmed by specific lab tests.I haven't received cancer treatment with antibodies in the last 3 weeks.I am on HIV medication with a low viral load and CD4 count over 300.I currently have an infection that is not under control.My white blood cell count is healthy or low due to my condition.I can swallow pills.My CLL has returned or didn't respond to initial treatment with prednisone, with or without rituximab.I have had cancer before, but it's not currently active.I do not have serious heart problems like recent heart attacks or severe heart failure.My blood clotting levels are within the normal range, or if I'm on blood thinners, they're at the right level for my treatment.I have been on a stable treatment for AIHA without dose changes for the last 4 weeks.I am not taking strong drugs that affect liver enzyme CYP3A4.I had skin cancer (not melanoma) or melanoma in situ, but it's now treated with no signs of the disease.I haven't taken venetoclax, PI3K inhibitors, or similar drugs recently.I have not taken Ibrutinib, Acalabrutinib, or similar drugs in the last year.I had a stem cell transplant within the last year or am on immunosuppressants for cGVHD.I do not have an active hepatitis B or C infection.My blood clotting time is within the normal range, or if I'm on blood thinners, it's within the therapeutic range.I am willing to switch from proton pump inhibitors to H2-receptor antagonists or antacids.I have not had a stroke or brain bleed in the last 6 months.I had early-stage cancer (like breast or cervical) that was treated, and now I show no signs of the disease.My kidney function, measured by creatinine clearance, is adequate.I haven't taken more than 60 mg/day of prednisone or its equivalent for over 2 weeks in the last month.I have been diagnosed with HIV.I had cancer treated to cure it and have been free of active disease for 2 years.I am taking vitamin K antagonists.I have or might have a brain infection known as PML.I have not had major surgery in the last 28 days.I am capable of having children and have not been surgically sterilized.You have a mental health condition or circumstances that may make it difficult for you to follow the study rules.My prostate cancer is being monitored without active treatment.I have tested negative for active hepatitis B infection.I have mostly recovered from side effects of my previous treatments.I can perform all my self-care but may not be able to do heavy physical work.I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.I have a history of bleeding disorders or currently have active bleeding.You have had a bad reaction to acalabrutinib in the past.
- 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
What are the FDA's thoughts on Acalabrutinib?
"Acalabrutinib falls into the Phase 2 category, which means that while there is some evidence to support its safety, none exists yet for its efficacy. Our team at Power gave it a rating of 2."
Is Acalabrutinib a new or experimental treatment?
"As of this moment, there are 107 independent clinical trials underway that are investigating Acalabrutinib. Of those active trials, 14 have reached Phase 3. The majority of the trials for Acalabrutinib are based in Boston, Massachusetts; however, 8852 different locations across the globe are running tests for this medication."
Are volunteers still being accepted for this program?
"This specific trial is not recruiting new patients at this time. However, if you are interested in autoimmune hemolytic anemia or Acalabrutinib clinical trials, there are 1821 and 107 studies respectively that are still enrolling candidates."
How many people are taking lenalidomide in this clinical trial at the most?
"This specific clinical trial is not currently seeking patients, as reflected by an update on 10/7/2022. However, there are 1821 other studies for autoimmune hemolytic anemia and 107 trials for Acalabrutinib that are actively looking for participants."
What is the main indication for Acalabrutinib?
"Acalabrutinib is most commonly used for treatment of renal dysfunction. It can also be administered to treat various conditions like chronic lymphocytic leukemia (cll), kidney failure, mantle cell lymphoma (mcl)."
What is the novelty of this research?
"Acalabrutinib was first studied in 2007 by Baxter Healthcare Corporation. After the initial 4640-person Phase 4 trial, the drug received approval and there are now 107 ongoing studies involving Acalabrutinib across 49 countries and 1218 cities."
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