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Acalabrutinib for Lymphoma
Study Summary
This trial is testing a new drug, Acalabrutinib, for people with a certain kind of cancer that has come back or doesn't respond to treatment.
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 • NCT04346199Trial Design
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- My high blood pressure is not controlled despite taking medication.I haven't had cancer treatment or been in a trial within the last 4 weeks.I have been treated with BTK inhibitors before.I have not had a stroke or brain bleed in the last 6 months.I am fully active or restricted in physically strenuous activity but can do light work.I have not had major surgery in the last 28 days.I do not have a bleeding disorder like hemophilia.I have uncontrolled AIHA or ITP.I need treatment with a strong medication that affects liver enzymes.I have enough tissue from my brain biopsy for further studies.I have had a serious brain bleed.I have no active cancer except for certain skin cancers or cancers I've been free from for 3+ years.I have an active disease affecting my whole body.I do not have serious heart problems or a recent heart attack.I cannot swallow pills or have a stomach condition that affects medication absorption.I have recovered from major side effects of my previous treatments.I am at least 18 years old.I am on blood thinners like warfarin.I have been tested for hepatitis B and C, and I am willing to undergo further testing if needed.I have DLBCL CNS lymphoma (for Phase I) or DLBCL PCNSL (for Phase II) and have undergone at least one CNS-targeted treatment.I have no active significant infections and no history of HIV or PML.My liver condition is severe, classified as Child-Pugh C.
- Group 1: Acalabrutinib Dose Escalation
- Group 2: Acalabrutinib Dose Expansion
- 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 is the enrollment figure for this research project?
"Affirmative, the information hosted on clinicaltrials.gov reveals that this scientific research is actively searching for volunteers. This experiment was posted initially on August 23rd 2021 and has been updated recently on January 5th 2022. A total of 49 participants are needed from two distinct locations."
What other scientific investigations have been done on Acalabrutinib's efficacy?
"Presently, there are 75 clinical trials for Acalabrutinib with 11 in their final phase. Although the most prominent sites administering this medication are located in Houston, Texas, 2427 medical centers across the globe have opened trials to further research this treatment option."
What medical ailments is Acalabrutinib typically utilized to address?
"Acalabrutinib is an effective treatment for Mantle cell lymphoma (MCL), Small Lymphocytic Lymphoma, and Chronic lymphocytic leukemia (CLL)."
Is there still an opportunity to join this experiment?
"Affirmative. Clinicaltrials.gov displays that this research endeavour is actively enrolling participants as of now. This trial was first posted on August 23rd 2021 and the details were most recently amended on January 5th 2022, with a goal to enlist 49 individuals across 2 sites."
Is this research endeavor unprecedented or has it been undertaken before?
"Acalabrutinib has been the subject of intensive research since 2014, when Acerta Pharma BV sponsored its inaugural clinical trial with 306 participants. This marked a successful completion of Phase 1 & 2 approvals for this drug and today there are 75 active studies taking place in 507 cities across 47 countries."
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