Study on Pirtobrutinib (LOXO-305) and Venetoclax for Treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05317936

Provider View

This clinical trial is exploring whether combining the drugs pirtobrutinib (LOXO-305) and venetoclax can help control chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have already received treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if using pirtobrutinib (LOXO-305) together with venetoclax can effectively reduce the presence of cancer cells in the blood of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already been treated with venetoclax. The study will measure how many patients achieve very low levels of cancer cells in their blood after 24 cycles of this combination therapy.

Description

In this study, patients will take pirtobrutinib (LOXO-305) and venetoclax by mouth every day for 28-day cycles. The treatment can continue for up to 24 cycles unless the disease progresses or side effects become too severe. If patients achieve a very low level of cancer cells in their blood after 24 cycles, they will stop the treatment. If not, they may continue taking pirtobrutinib alone for up to 36 cycles.

The study will also look at how many patients achieve complete remission, how long it takes to see the best response, and the safety of the drug combination. Patients will be monitored for side effects and overall health during and after the treatment. Follow-up visits will occur 4 weeks after treatment ends and then every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Previously treated with venetoclax for at least 12 cycles and still have detectable cancer cells in the blood.
  • Aged 18 years or older.
  • In good general health with a performance status score of 0 to 2.
  • Have normal liver and kidney function as indicated by specific blood tests.
  • Have adequate blood cell counts, including platelets and neutrophils.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
  • Men must agree to use effective contraception during the study and for 30 days after.
  • Able to provide informed consent and follow study requirements.

Exclusion Criteria

  • Have a history of certain other types of cancer or blood disorders.
  • Have cancer that has spread to the brain or central nervous system.
  • Have had severe heart problems or uncontrolled heart rhythm issues.
  • Have active infections like hepatitis B, hepatitis C, or HIV.
  • Have significant health issues that could interfere with the study.
  • Have had major surgery within 4 weeks before starting the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are taking certain medications that could interfere with the study drugs.
  • Have received a live vaccine within 28 days before starting the study.
  • Have known allergies to the study drugs or their components.

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