Study on Pirtobrutinib and Venetoclax with MRD Detection for Untreated Chronic Lymphocytic Leukemia

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05677919

Provider View

This clinical trial is exploring how well the drugs pirtobrutinib and venetoclax work together to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received prior treatment. The study also uses a special blood test to detect minimal residual disease (MRD) to help decide how long treatment should last.

Patient Parameters

Program Overview

This study is testing the effectiveness of two drugs, pirtobrutinib and venetoclax, in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before. The study also uses a blood test to detect a small number of cancer cells remaining after treatment, known as minimal residual disease (MRD), to help guide future treatment decisions. The drugs work by stopping cancer cells from growing or dividing. The study aims to see if this approach can help manage CLL or SLL more effectively.

Description

The main goal of this study is to see how many patients have no detectable cancer cells in their blood and bone marrow after 15 cycles of treatment with pirtobrutinib and venetoclax. Secondary goals include measuring how long patients stay free from cancer progression, the overall response to treatment, and any side effects from the drugs. The study also looks at how the presence of minimal residual disease (MRD) relates to treatment response and outcomes.

Participants will take pirtobrutinib daily for 28 days in each cycle and start taking venetoclax daily from the fourth cycle. Treatment can continue for up to 27 cycles unless the disease progresses or side effects become unacceptable. Throughout the study, participants will have various tests, including CT, MRI, or PET/CT scans, bone marrow tests, and blood sample collections. They may also have heart function tests during the screening phase.

After finishing the treatment, participants will have follow-up visits 30 days later and every six months for up to three years, and then every six months for up to five years to monitor their health and survival.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • No previous treatment for CLL/SLL, except for certain short-term corticosteroid treatments.
  • Must provide written informed consent.
  • For SLL patients, must have a measurable B-cell clone in blood or bone marrow.
  • Must meet at least one of the following treatment criteria:
    • Worsening anemia or low platelet counts.
    • Large or growing spleen or lymph nodes.
    • Rapidly increasing lymphocyte count.
    • Autoimmune complications not responding to steroids.
    • Symptoms like significant weight loss, fatigue, fever, or night sweats.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have adequate blood counts and organ function based on specific tests.
  • Women of childbearing potential must agree to use effective birth control during and after treatment.
  • Men must agree not to donate sperm during and after treatment.
  • Must be willing to provide samples for research and return for follow-up visits.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Evidence of Richter transformation or central nervous system involvement.
  • Active uncontrolled autoimmune complications.
  • Taking other investigational treatments for CLL/SLL.
  • Need for certain medications that interact with study drugs.
  • Recent use of live vaccines.
  • Conditions that prevent taking oral medications.
  • History of bleeding disorders.
  • Positive for HIV, hepatitis B, or hepatitis C.
  • Severe heart conditions or recent heart attacks.
  • Uncontrolled infections or other serious illnesses.
  • Recent major surgery.
  • Other active cancers requiring treatment.
  • Known allergies to study drugs.

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