Pilot Study of Acalabrutinib for Treating Relapsed or Hard-to-Treat Primary and Secondary CNS Lymphomas

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04548648

Provider View

This study is testing if the drug acalabrutinib is safe and effective for patients with central nervous system (CNS) lymphoma that has returned or is difficult to treat. Acalabrutinib is not yet approved for CNS lymphoma but has shown promise in similar conditions.

Patient Parameters

Program Overview

The study aims to find out if acalabrutinib can safely and effectively control CNS lymphoma that has come back or is hard to treat. Currently, there are no approved treatments for relapsed CNS lymphoma. Acalabrutinib is similar to another drug, ibrutinib, which has shown positive results in treating CNS lymphomas. This study will see if acalabrutinib can shrink cancer cells more effectively. Participants will also receive isavuconazole to prevent fungal infections during treatment.

Description

This study involves giving acalabrutinib to patients with relapsed CNS lymphoma to see if it can help control the disease. Up to 16 patients will be enrolled, aiming for 15 to complete the study. The treatment will continue unless the disease worsens, side effects become too severe, the patient becomes pregnant, or the patient decides to stop. Patients will be monitored for up to 5 years or until they pass away.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to participate in all study procedures, including taking capsules and tablets.
  • Understand the study's purpose and risks and provide signed consent.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 2 or less.
  • Confirmed diagnosis of CNS lymphoma through biopsy or MRI.
  • Have B-cell Non-Hodgkin Lymphoma.
  • No evidence of lymphoma outside the CNS.
  • Have received at least one prior chemotherapy treatment for CNS lymphoma.
  • Adequate organ function based on specific blood tests.
  • Able to take isavuconazole to prevent fungal infections.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.

Exclusion Criteria

  • Recent cancer treatment or unresolved side effects from previous treatments.
  • Recent brain radiotherapy.
  • Participation in another study or investigational treatment recently.
  • Pregnant or breastfeeding.
  • Active cerebrospinal fluid involvement requiring ongoing treatment.
  • Previous treatment with a BTK inhibitor.
  • Severe liver problems.
  • Taking medications that cannot be stopped or replaced.
  • Need for certain blood thinners or proton pump inhibitors.
  • Significant heart disease or recent heart attack.
  • History of gastrointestinal issues affecting absorption.
  • Active infections or history of certain viral infections.
  • Known allergies to study drugs.
  • History of bleeding disorders or autoimmune conditions.
  • Recent major surgery.
  • Positive for certain hepatitis infections without proper treatment.
  • Any condition that the investigator believes makes the patient unsuitable for the study.

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