Study on Venetoclax and Zanubrutinib for Treating Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Sponsor: Kerry Rogers

Sponsor score: 0

ClinicalTrials ID:NCT07734038

Provider View

This clinical trial is exploring the effects of combining two drugs, venetoclax and zanubrutinib, to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study aims to see if this combination can safely reduce cancer cells in patients who have not been treated before or have been in remission for at least two years.

Patient Parameters

Program Overview

The purpose of this study is to test if using venetoclax together with zanubrutinib can effectively reduce cancer cells in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax works by blocking a protein that cancer cells need to survive, while zanubrutinib stops cancer cells from growing by targeting a specific protein. This study is for patients who have either never received treatment or have been in remission for at least two years.

Description

The main goal of this study is to find out how many patients achieve undetectable levels of cancer cells after receiving a fixed-duration treatment with venetoclax and zanubrutinib. The study will also look at how well patients respond to the treatment, how long the response lasts, and the time until the next treatment is needed. Additionally, the study will monitor any side effects from the treatment.

Patients are divided into two groups: those who have never been treated (Frontline Cohort) and those who have completed initial treatment (Second Line Cohort). Both groups will receive zanubrutinib daily, and starting from the fourth cycle, they will also take venetoclax daily. The treatment cycles repeat every 28 days, with the Frontline Cohort receiving up to 15 cycles and the Second Line Cohort up to 27 cycles, unless the disease progresses or side effects become unacceptable.

Throughout the study, patients will undergo regular blood tests, bone marrow biopsies, and imaging scans to monitor their progress. After completing the treatment, patients will have follow-up visits every three months, and then every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on specific medical guidelines.
  • Aged 18 years or older.
  • Need treatment as defined by medical guidelines.
  • For the Frontline Cohort: Patients who have never received treatment for CLL/SLL.
  • For the Second Line Cohort: Patients who have previously received a specific type of treatment involving venetoclax and other medications, and have been in remission for at least two years.
  • Only one prior line of therapy is allowed.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Willing and able to complete study activities and follow treatment plans.
  • Agree to use effective birth control during and after treatment.

Exclusion Criteria

  • For the Second Line Cohort: Patients whose cancer progressed during or within two years of completing previous treatment.
  • For the Frontline Cohort: Patients with specific genetic mutations.
  • Active transformation of CLL/SLL into a more aggressive form.
  • Previous treatment with zanubrutinib.
  • Allergies to any components of the study drugs.
  • Need for certain blood-thinning medications during the study.
  • Recent history of stroke or significant bleeding disorders.
  • Difficulty swallowing pills or absorbing medications.
  • Active second cancer unless in remission and with a life expectancy over two years.
  • Uncontrolled autoimmune conditions or infections.
  • Significant heart disease or abnormal heart rhythms.
  • Active hepatitis B or C infections.
  • Use of certain medications that interact with the study drugs.
  • Consumption of grapefruit or related products during the study.
  • Pregnancy, breastfeeding, or planning to become pregnant during the study.
  • Recent major surgery or live vaccinations.
  • Currently incarcerated or with central nervous system involvement by CLL/SLL.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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