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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib for CNS Lymphoma
Phase 2
Recruiting
Led By Christopher Dittus
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at the time of consent.
Subject has B-cell Non-Hodgkin Lymphoma.
Must not have
Subjects who are hepatitis C antibody positive must have a negative polymerase chain reaction (PCR) result. Those who are hepatitis C PCR positive will be excluded.
Previous exposure to a Bruton Tyrosine Kinase (BTK) inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Summary
This trial will test whether giving acalabrutinib is safe and effective in controlling relapsed central nervous system (CNS) lymphoma.
Who is the study for?
Adults over 18 with relapsed CNS lymphoma who've had at least one prior chemotherapy treatment can join this trial. They must not be pregnant, breastfeeding, or have severe liver issues. Participants need to use effective contraception and should not have a history of certain heart diseases or infections like HIV.
What is being tested?
The study is testing acalabrutinib's safety and effectiveness for controlling relapsed CNS lymphoma. There are no FDA-approved treatments for this condition yet. Acalabrutinib targets cancer cells similarly to an approved drug for another lymphoma type. Isavuconazole is also given to prevent fungal infections during the trial.
What are the potential side effects?
Possible side effects include bleeding risks, heart rhythm problems, allergic reactions, liver enzyme changes, and increased risk of infection due to immune system suppression by acalabrutinib and isavuconazole.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have B-cell Non-Hodgkin Lymphoma.
Select...
My blood counts, kidney, liver, and clotting functions are within safe ranges.
Select...
I have a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.
Select...
I have had chemotherapy for CNS lymphoma before.
Select...
I agree to use two forms of birth control or abstain from sex while on acalabrutinib.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been tested for hepatitis C and my PCR results are negative.
Select...
I have been treated with a BTK inhibitor before.
Select...
I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.
Select...
I have HIV or another serious infection that is not under control.
Select...
I have a condition that affects how my body absorbs food.
Select...
I do not have any serious infections.
Select...
I need ongoing spinal fluid treatment for my cancer.
Select...
I have a family history of short QT syndrome.
Select...
I am not on any medication that cannot be stopped or replaced as per the trial's requirements.
Select...
I have a bleeding disorder or am currently experiencing active bleeding.
Select...
I had major surgery less than 28 days before starting acalabrutinib.
Select...
I have a history of uncontrolled AIHA or ITP.
Select...
My liver function is not severely impaired.
Select...
I am currently undergoing chemotherapy or immunotherapy for cancer.
Select...
I finished my last cancer treatment less than 14 days ago or still have side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Complete response (CR) rate
Duration of response (DoR)
Number of different types of toxicities
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Open-label, single-armExperimental Treatment2 Interventions
A multicenter open-label, single-arm, phase 2 study designed to investigate the antitumor effects of acalabrutinib in subjects with relapsed primary central nervous system lymphoma (PCNSL), and relapsed secondary CNS lymphoma (SCNSL) with no evidence of current systemic disease. Subjects will receive acalabrutinib at the dose of 100 mg every 12 hours. Prophylactic administration of broad spectrum triazole antifungal agent isavuconazole will be performed while subjects receive acalabrutinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Isavuconazole
2020
Completed Phase 3
~1720
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
89,879 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,793 Total Patients Enrolled
Christopher DittusPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been tested for hepatitis C and my PCR results are negative.I have been treated with a BTK inhibitor before.I am 18 years old or older.I have B-cell Non-Hodgkin Lymphoma.I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.I have HIV or another serious infection that is not under control.My blood counts, kidney, liver, and clotting functions are within safe ranges.I do not have serious heart problems or recent heart attacks.I have another cancer type, but it won't affect this cancer treatment's safety or results.I can take isavuconazole to prevent fungal infection while on acalabrutinib treatment.I have a condition that affects how my body absorbs food.I have a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.I do not have any serious infections.I need ongoing spinal fluid treatment for my cancer.I have been tested for hepatitis B and agree to ongoing tests if needed.I can take part in all study activities and can swallow pills without trouble.I am a woman who can have children and have a recent negative pregnancy test.I have a family history of short QT syndrome.I am not on any medication that cannot be stopped or replaced as per the trial's requirements.I have a bleeding disorder or am currently experiencing active bleeding.I had major surgery less than 28 days before starting acalabrutinib.I have had chemotherapy for CNS lymphoma before.I am taking blood thinners like warfarin or direct oral anticoagulants.I have a history of uncontrolled AIHA or ITP.I have had brain radiotherapy but finished it more than 28 days ago for WBRT or more than 14 days ago for SRS.I can perform daily activities with little or no assistance.My liver function is not severely impaired.I am currently undergoing chemotherapy or immunotherapy for cancer.I have not had a live virus vaccine in the last 28 days.I finished my last cancer treatment less than 14 days ago or still have side effects.I need medication for stomach acid and can switch to other types if needed.I have had a stroke or brain bleed in the last 6 months.My recent scans show no signs of lymphoma spreading in my body.I agree to use two forms of birth control or abstain from sex while on acalabrutinib.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label, single-arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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