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Two drugs, pirtobrutinib and venetoclax, to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

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18 and older

Phase 2

1 Location

NCT06466122

Clinical Trial Goal


To find out if the combination of pirtobrutinib and venetoclax is safe and works well to treat CLL or SLL

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have CLL or SLL
  • Have been treated with a BTK inhibitor (BTKi), and did not see improvement. Your doctor can tell you this
  • Are currently taking one of the following:
    • Acalabrutinib
    • Ibrutinib
    • Zanubrutinib 
  • Do not have lymphoma in your brain or spinal cord
  • Have not been treated with venetoclax for more than about 1 year 
  • Have not been treated with any of the following in the last 2 months:
    • Allogeneic (cells from a donor) blood or marrow transplant (BMT)
    • Autologous (your own cells) BMT
    • CAR T-cell therapy
  • Do not have graft-versus-host-disease (GVHD)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Pirtobrutinib is a small molecule inhibitor that blocks BTK in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • Pirtobrutinib – A pill that you take by mouth 1 time each day
  • Venetoclax –  A pill that you take by mouth 1 time each day

You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 1.5 years. 

The Food and Drug Administration (FDA) has approved pirtobrutinib to treat mantle cell lymphoma (MCL) and venetoclax to treat acute myeloid leukemia (AML), CLL or SLL. Using them in this combination to treat CLL or SLL that has not gotten better after treatment with a BTKi is new and unproven. 

Contacts


The Ohio State University Comprehensive Cancer Center, 800-293-5066, OSUCCCClinicaltrials@osumc.edu

Locations


Ohio State University Comprehensive Cancer CenterRECRUITING

Columbus, Ohio
Kerry A. Rogers, MD, 614-293-3196

ClinicalTrials.gov record


NCT06466122. First posted on 6/20/24

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