Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byAlessandra Ferrajoli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

To learn if the combination of LOXO-305 (pirtobrutinib) and venetoclax can help to control previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Eligibility Criteria

Adults with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have completed at least 12 cycles of venetoclax and still have detectable minimal residual disease. Participants must be in generally good health, with adequate organ function and blood counts, not pregnant or breastfeeding, willing to use effective contraception, and without certain heart conditions or other serious medical issues.

Inclusion Criteria

Activated partial thromboplastin time (aPTT) or partial thromboplastin time and prothrombin time (PT) or international normalized ratio (INR) not greater than 1.5 x ULN

Hemoglobin >= 8 mg/dL

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN, unless clearly due to documented disease involvement, in which case ALT and AST =< 5.0 x ULN

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Exclusion Criteria

I haven't had a stem cell transplant or CAR-T therapy in the last 60 days and don't have active GVHD, need for anti-cytokine therapy, symptoms of neurotoxicity > grade 1, or uncontrolled auto-immune cytopenia.

I had a major bleeding event while on a BTK inhibitor.

I have been treated with a BTK inhibitor like nemtabrutinib before.

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Treatment Details

Interventions

Pirtobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Venetoclax (B-cell Lymphoma-2 (BCL-2) Inhibitor)

Trial OverviewThe trial is testing the effectiveness of combining a new drug called pirtobrutinib (LOXO-305) with an existing treatment, venetoclax, to see if this combination can better control CLL/SLL after previous treatments. The goal is to eliminate any remaining cancer cells that were not cleared by prior therapy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Pirtobrutinib+venetoclaxExperimental Treatment2 Interventions

Pirtobrutinib by mouth at the same time each day Venetoclax by mouth at the same time each day.

Venetoclax is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Venclexta for: