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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
Subject must have received at least one prior line of chemotherapy for primary or secondary CNS lymphoma. There is no limit on the number of prior treatment regimens.
Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I have had chemotherapy for CNS lymphoma before.
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I can take part in all study activities and can swallow pills without trouble.
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I am 18 years old or older.
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I have B-cell Non-Hodgkin Lymphoma.
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My blood counts, kidney, liver, and clotting functions are within safe ranges.
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I have B-cell Non-Hodgkin Lymphoma.
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I have a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.
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My blood counts, kidney, liver, and clotting functions are within safe ranges.
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I agree to use two forms of birth control or abstain from sex while on acalabrutinib.
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I can perform daily activities with little to no assistance.
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I have had chemotherapy for CNS lymphoma before.
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My recent scans show no signs of lymphoma spreading in my body.
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I am a woman who can have children and have a recent negative pregnancy test.
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I have another cancer, but it won't affect this trial's treatment.
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I am 18 years old or older.
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I can take isavuconazole to prevent fungal infections while on acalabrutinib treatment.
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I agree to use two forms of birth control or abstain from sex while on acalabrutinib.
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I have a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Trial 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
~2030
Isavuconazole
2020
Completed Phase 3
~1720

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,155 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,528,191 Total Patients Enrolled
Christopher DittusPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04548648 — Phase 2
Central Nervous System Lymphoma Research Study Groups: Open-label, single-arm
Central Nervous System Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04548648 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04548648 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the odds of any negative side effects from this treatment?

"While there is some evidence that this intervention is safe, it lacks the same level of clinical data to support its efficacy. Our team at Power estimates a score of 2."

Answered by AI

Could I enroll in this clinical trial?

"This clinical trial is admitting 16 people, within the ages of 18 and 99 who have lymphoma. It is required that participants also meet the following criteria: They must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)., The subject has adequate organ function as demonstrated by: System Laboratory Value Hematological* Absolute Neutrophil Count (ANC) ≥ 1 x 109/L Platelets ≥ 75 x 109/L Renal* Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft"

Answered by AI

Would this medical research be open to subjects who are senior citizens?

"The age limit to participate in this clinical trial is 18-99. For context, 313 other trials are taking place that involve patients under the age of 18 while 1677 studies are focused on those over 65 years old."

Answered by AI

What is this treatment most commonly used to heal?

"The small lymphocytic lymphoma often responds well to this treatment. Additionally, this medication has shown efficacy in treating other conditions such as mucormycosis, ≥ 1 prior therapy for mantle cell lymphoma, and chronic lymphocytic leukemia (cll)."

Answered by AI

Are new participants still being sought for this experiment?

"That is accurate. The clinical trial mentioned is, as of now, looking for potential participants. It was first posted on October 15th 2020 and was edited most recently on March 24th 2022. There are 16 spots available at 3 different locations."

Answered by AI

How many test subjects are involved in this experiment?

"Yes, the medical trial is still open for recruitment and this can be seen on clinicaltrials.gov. The study was first posted on October 15th 2020 and was most recently updated on March 24th 2022. So far, 16 patients have been enrolled at 3 different sites."

Answered by AI

Has this type of research been conducted before?

"This treatment regimen has been under investigation since 2014. The first trial was sponsored by Acerta Pharma BV and took place that same year. It involved 306 participants. After the initial study, this treatment received Phase 1 & 2 drug approval in _____ . As of today, there are 80 live studies involving this treatment being conducted across 508 cities in 47 countries."

Answered by AI
~8 spots leftby Feb 2028