Study on Nemtabrutinib and Venetoclax for Treating Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: Jennifer Woyach

Sponsor score: 0

ClinicalTrials ID:NCT07557056

Provider View

This clinical trial is exploring how well the combination of two drugs, nemtabrutinib and venetoclax, works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These drugs aim to stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, nemtabrutinib and venetoclax, to see how effective they are in treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Nemtabrutinib blocks a protein called BTK, which is found at high levels in these cancers, potentially stopping cancer cells from growing. Venetoclax blocks another protein, BCL-2, which helps cancer cells survive. By using these drugs together, researchers hope to kill more cancer cells in patients with CLL or SLL.

Description

The main goal of this study is to see if the combination of nemtabrutinib and venetoclax can reduce cancer cells to undetectable levels in the blood after 14 cycles of treatment in patients who have not received prior treatment for CLL or SLL. Researchers will also look at the safety of this drug combination, how long patients remain free from cancer progression, and how long it takes before they need another treatment. Additionally, the study will assess how patients respond to the treatment and any changes in their fatigue and quality of life.

Patients will take nemtabrutinib daily for 28 days in each cycle. Starting from the third cycle, they will also take venetoclax daily. Each cycle lasts 28 days, and the treatment can continue for up to 14 cycles unless the cancer progresses or side effects become unacceptable. Throughout the trial, patients will undergo various tests, including CT scans, bone marrow tests, and blood tests.

After finishing the treatment, patients will have follow-up visits every 12 weeks to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to specific medical guidelines.
  • At least 18 years old.
  • Have not received prior treatment for CLL/SLL, except for certain therapies like local radiation or medications for symptom control.
  • Meet specific criteria for needing treatment, such as enlarged spleen or lymph nodes, rapid increase in white blood cells, or certain symptoms like weight loss or fever.
  • Have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Have adequate blood cell counts and organ function, unless low counts are due to the disease itself.
  • Willing to participate in all study procedures and provide informed consent.
  • Agree to use effective contraception during the study and for a specified time after the last dose of the study drugs.
  • Able to swallow oral medication.
  • If positive for hepatitis B or C, must have controlled viral load and be on appropriate antiviral therapy.
  • If HIV positive, must have controlled viral load and be on stable antiretroviral therapy.

Exclusion Criteria

  • Have another type of cancer that affects life expectancy or could interfere with the study.
  • Have significant heart disease or recent heart attack.
  • Have active hepatitis B or C infection.
  • Unable to swallow pills or have digestive issues affecting drug absorption.
  • Have a type of CLL/SLL transformation known as Richter transformation.
  • Have active cancer spread to the brain or spinal cord.
  • Have an active infection requiring treatment.
  • Have had an AIDS-defining infection in the past year.
  • Have any condition or treatment that could interfere with the study or is not in the patient's best interest.
  • Have significant heart rhythm issues or other serious heart conditions.
  • Have a known allergy to the study drugs.
  • Are pregnant or breastfeeding.
  • Have received certain other cancer treatments recently.
  • Are currently in another clinical trial or taking investigational drugs.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have not fully recovered from major surgery.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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