Study on Acalabrutinib for Patients with Chronic Lymphocytic Leukemia (CLL) Who Cannot Tolerate Ibrutinib

Sponsor: Acerta Pharma BV

Sponsor score: 0

ClinicalTrials ID:NCT02717611

This clinical trial is testing the effectiveness and safety of the drug Acalabrutinib in patients with Chronic Lymphocytic Leukemia (CLL) who have not responded to previous treatments and cannot tolerate Ibrutinib.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well Acalabrutinib works and how safe it is for patients with Chronic Lymphocytic Leukemia (CLL) who have tried other treatments but cannot continue with Ibrutinib due to side effects. The study involves multiple centers and is open to patients who meet specific criteria.

Description

This study is designed to test Acalabrutinib, a medication for patients with Chronic Lymphocytic Leukemia (CLL) who have not responded to previous treatments and cannot tolerate Ibrutinib. The study will involve 60 participants and will take place at multiple locations. Participants will receive Acalabrutinib and will be monitored for its effectiveness and any side effects. The study aims to provide an alternative treatment option for those who have had difficulties with Ibrutinib.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a prior diagnosis of Chronic Lymphocytic Leukemia (CLL).
  • Have received at least one previous treatment for CLL.
  • Cannot tolerate Ibrutinib due to side effects.
  • Have documented disease progression after stopping Ibrutinib, according to specific medical criteria.
  • Be willing and able to participate in all study evaluations and procedures, including swallowing capsules.
  • Have a performance status score of 2 or less, indicating they are able to carry out all self-care but unable to carry out any work activities.

Exclusion Criteria

  • Have ongoing side effects from Ibrutinib.
  • Have received any other cancer treatment for CLL between stopping Ibrutinib and starting this study.
  • Have previously used a BCL-2 inhibitor like Venetoclax.
  • Have had another type of cancer in the past, unless it was treated and has been in remission for at least 2 years.
  • Have significant heart disease, such as uncontrolled heart rhythm problems or recent heart attack.
  • Have digestive issues that affect the absorption of medication.
  • Have evidence of disease progression on Ibrutinib or any BTK inhibitor.
  • Have CLL that has spread to the central nervous system.
  • Have active infections like HIV or hepatitis B or C.
  • Have uncontrolled autoimmune blood disorders.
  • Have had a stroke or brain bleed in the past 2 months.
  • Have a history of bleeding disorders.
  • Have had a stomach ulcer diagnosed recently.
  • Have had major surgery within the last 28 days.
  • Require treatment with certain medications that interact with the study drug.

Locations

FACILITYZIPCITYSTATE
Research Site85704TucsonArizona
Research Site94520ConcordCalifornia
Research Site92093La JollaCalifornia
Research Site94304Palo AltoCalifornia
Research Site20007Washington D.C.District of Columbia
Research Site60611ChicagoIllinois
Research Site11042Lake SuccessNew York
Research Site10021New YorkNew York
Research Site43210ColumbusOhio
Research Site37203NashvilleTennessee

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