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Study Comparing Nemtabrutinib, Ibrutinib, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two diseases: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of blood cancers that affect the white blood cells. The study will compare the effectiveness of a new treatment called Nemtabrutinib with two existing treatments, Ibrutinib and Acalabrutinib. These medications are taken orally in tablet form and are designed to help manage these conditions by targeting specific proteins in cancer cells.

The purpose of the study is to see how well Nemtabrutinib works compared to the other two treatments in people who have not yet received treatment for their CLL or SLL. Participants will be randomly assigned to receive either Nemtabrutinib or one of the other two medications chosen by the study doctor. The study will last for a period of up to 108 weeks, during which participants will take the medication daily and attend regular check-ups to monitor their health and the progress of the disease.

Throughout the study, doctors will assess how the disease responds to the treatment and how long participants remain free from disease progression. They will also monitor overall survival and any side effects experienced by participants. The study aims to provide valuable information on the effectiveness and safety of Nemtabrutinib compared to the current standard treatments for CLL and SLL.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group receives nemtabrutinib, while the other group receives a comparator drug, which is either ibrutinib or acalabrutinib. The choice of comparator is determined by the investigator.

  2. Step 2

    Medication administration

    Participants take their assigned medication orally in the form of tablets. The specific dosage and frequency of administration are determined by the study protocol and communicated to participants by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring and assessments to evaluate their response to the treatment. This includes measuring the Objective Response Rate (ORR) and Progression-Free Survival (PFS) according to specific criteria. These assessments are conducted by a Blinded Independent Central Review (BICR).

  4. Step 4

    Safety evaluations

    Participants are monitored for any adverse events or side effects that may occur during the study. The number of participants experiencing adverse events and those who discontinue treatment due to these events are recorded.

  5. Step 5

    Study duration

    The study is expected to continue until September 30, 2032. Participants remain in the study for the duration specified in the protocol, unless they choose to withdraw or are advised to discontinue by the study team.

Who can join the trial?

8 criteria

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with active disease that needs treatment.
  • Has at least one sign of disease presence.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which means the person is fully active or has some symptoms but can take care of themselves, checked within 7 days before starting the study.
  • Can swallow and keep oral medication.
  • If positive for hepatitis B, must have taken antiviral treatment for at least 4 weeks and have no detectable virus in the blood before starting the study.
  • If there is a history of hepatitis C infection, the virus must not be detectable in the blood at the start of the study.
  • If living with human immunodeficiency virus (HIV), must meet all other eligibility criteria.
  • Both males and females can participate.

Who cannot join the trial?

2 criteria

  • Patients who have already received treatment for **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)** cannot participate. This means if you have been treated for these conditions before, you are not eligible.
  • Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may need special protection or care, such as children or those with certain disabilities.
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Investigated drugs

  • Nemtabrutinib

    is an investigational medication being studied for its potential to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is being compared to other treatments to see how well it works in improving the overall response rate and progression-free survival in patients who have not been treated before.

  • Ibrutinib

    is a medication used to treat certain types of blood cancers, including chronic lymphocytic leukemia (CLL). It works by blocking a specific protein that helps cancer cells grow and survive. In this study, it is used as a comparator to evaluate the effectiveness of nemtabrutinib.

  • Acalabrutinib

    is another medication used to treat chronic lymphocytic leukemia (CLL). Similar to ibrutinib, it targets a protein that is important for the growth and survival of cancer cells. In this trial, it serves as a comparator to assess how well nemtabrutinib performs in treating the disease.

What is already known about the treatment

  • Nemtabrutinib

    Nemtabrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). It is not yet widely available in medical practice as it is still under investigation. The main therapeutic indication for nemtabrutinib is to manage CLL and SLL by inhibiting specific proteins involved in the growth and survival of cancer cells. It belongs to the pharmacological class of Bruton's tyrosine kinase (BTK) inhibitors, which work by blocking the BTK enzyme, thereby interfering with cancer cell signaling and proliferation.

  • Ibrutinib

    Ibrutinib is an oral medication that is already approved and used in the treatment of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). It is well-documented in medical literature and is a standard treatment option for these conditions. Ibrutinib works by inhibiting Bruton's tyrosine kinase (BTK), a key enzyme in the signaling pathways that promote the growth and survival of cancer cells. By blocking BTK, ibrutinib helps to slow down or stop the progression of the disease.

  • Acalabrutinib

    Acalabrutinib is also an oral medication used in the treatment of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). It is approved for medical use and is supported by extensive research. Acalabrutinib functions as a Bruton's tyrosine kinase (BTK) inhibitor, similar to ibrutinib, and works by disrupting the signaling pathways that cancer cells use to grow and survive. This action helps to control the progression of the disease.

Investigated diseases

  • Small Lymphocytic Lymphoma (SLL)

    This is a type of cancer that affects the lymphocytes, which are a kind of white blood cell. It is closely related to chronic lymphocytic leukemia (CLL) and often considered the same disease, differing mainly in where the cancer cells are found. In SLL, the cancer cells are primarily located in the lymph nodes, whereas in CLL, they are mostly in the blood and bone marrow. The disease progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. Over time, it can affect the body's ability to fight infections.

  • Chronic Lymphocytic Leukemia (CLL)

    This is a type of cancer that starts in the bone marrow and affects the blood, specifically targeting the lymphocytes. It is characterized by the slow accumulation of abnormal lymphocytes in the blood, bone marrow, and lymphoid tissues. CLL progresses gradually and may not cause symptoms for years. As it advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The disease can eventually interfere with the production of normal blood cells.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501697-19-01Protocol codeMK-1026-011Estimated enrolment1 355 patientsSponsorMerck Sharp & Dohme LLC

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