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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

No Placebo-Only Group

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 below

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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 a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.

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I have had chemotherapy for CNS lymphoma before.

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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:

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I have been tested for hepatitis C and my PCR results are negative.

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I have been treated with a BTK inhibitor before.

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I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.

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I have HIV or another serious infection that is not under control.

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I have a condition that affects how my body absorbs food.

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I do not have any serious infections.

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I need ongoing spinal fluid treatment for my cancer.

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I have a family history of short QT syndrome.

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I am not on any medication that cannot be stopped or replaced as per the trial's requirements.

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I have a bleeding disorder or am currently experiencing active bleeding.

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I had major surgery less than 28 days before starting acalabrutinib.

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I have a history of uncontrolled AIHA or ITP.

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My liver function is not severely impaired.

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I am currently undergoing chemotherapy or immunotherapy for cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Complete response (CR) rate

Duration of response (DoR)

Number of different types of toxicities

+2 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label, single-armExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

0 / 21Eligibility criteria met