RecruitingPhase 2NCT06466122

Pirtobrutinib (LOXO-305) and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKi

Phase 2 Study of Combination Pirtobrutinib (LOXO-305) and Venetoclax in CLL Patients With Resistance to Covalent BTKi


Sponsor

Kerry Rogers

Enrollment

30 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well pirtobrutinib (LOXO-305) and venetoclax works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that remains despite treatment (resistant) with covalent bruton tyrosine kinase inhibitors (BTKi). Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the a protein that signals cancer cells to multiply. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Giving pirtobrutinib and venetoclax may kill more cancer cells in patients with CLL or SLL that is resistant to covalent BTKi.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — pirtobrutinib and venetoclax — for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has become resistant to standard BTK inhibitor drugs (like ibrutinib or acalabrutinib). **You may be eligible if...** - You have confirmed CLL or SLL that is progressing despite treatment with ibrutinib, acalabrutinib, or zanubrutinib - You are 18 or older and in reasonably good functional health (ECOG 0-2) - You are currently still taking your BTK inhibitor drug **You may NOT be eligible if...** - Your CLL/SLL is not progressing on a BTK inhibitor - You have had prior treatment with venetoclax - You have significant organ problems that would prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREComputed Tomography

Undergo CT

DRUGPirtobrutinib

Given PO

DRUGVenetoclax

Given PO


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06466122


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