Study on Using Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06839872

Provider View

This clinical trial is exploring the effectiveness and safety of a drug called pirtobrutinib for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have not responded to their initial treatment with acalabrutinib.

Patient Parameters

Program Overview

The aim of this study is to see if pirtobrutinib can help patients with CLL or SLL who have not responded to their first treatment with acalabrutinib. Some patients who do not respond to pirtobrutinib will be given acalabrutinib again to see if it can work a second time. The study will last up to 3 years for each participant. Patients taking only pirtobrutinib will visit the clinic monthly for the first 6 months, then every 3 months for the next year, and twice in the last 6 months. If they switch back to acalabrutinib, they will visit monthly for 6 months, then twice in the next 6 months.

Description

This study is designed to test the effectiveness and safety of pirtobrutinib in patients with CLL or SLL who have not responded to their initial treatment with acalabrutinib. If pirtobrutinib does not work, some patients will be given acalabrutinib again to see if it can be effective a second time. The study will last up to 3 years for each participant. Patients taking only pirtobrutinib will have monthly clinic visits for the first 6 months, then every 3 months for the next year, and twice in the last 6 months. If they switch back to acalabrutinib, they will have monthly visits for 6 months, then twice in the next 6 months.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have received acalabrutinib as the first treatment for CLL/SLL and have not responded to it.
  • Must be eligible for a second treatment based on specific medical criteria.
  • Must be in good overall health with a performance status score of 0, 1, or 2.
  • Must have good organ and bone marrow function.
  • Must have normal blood clotting ability.
  • Must have a documented start date for their first acalabrutinib treatment.
  • Can only switch back to acalabrutinib if they do not respond to pirtobrutinib.

Exclusion Criteria

  • Had major surgery within 30 days and not fully recovered.
  • Had major bleeding or severe heart rhythm issues with previous BTK inhibitor treatment.
  • Have a bleeding disorder like hemophilia.
  • Had a stroke or brain bleed in the last 6 months.
  • Have serious heart disease.
  • Have a history of a specific brain infection (PML).
  • Have an active serious infection.
  • Are HIV positive.
  • Have active hepatitis B or C.
  • Have cancer affecting the brain or spinal cord.
  • Have active autoimmune blood disorders.
  • Have a history of other cancers.
  • Need blood thinners like warfarin.
  • Had a live vaccine within 28 days.
  • Need certain medications that affect how the study drug works.

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