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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Hospital Universitario De Salamanca Salamanca Spain
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal

Other Sites

Site Name City Country Status
Evangelismos S.A. Athens Greece
Pratia Hematologia Sp. z o.o. Katowice Poland
University General Hospital Of Ioannina Ioannina Greece
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin Germany
Region Sjaelland Holbæk Denmark
Sykehuset I Vestfold HF Tonsberg Norway
Odense University Hospital Odense Denmark
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Champalimaud Clinical Centre Lisbon Portugal
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Dr. Vehling-Kaiser MVZ GmbH Landshut Germany
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Hospital Universitario De Canarias La Laguna Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Kliniken Maria Hilf GmbH Moenchengladbach Moenchengladbach Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Institut Fuer Versorgungsforschung In Der Onkologie GbR Koblenz Germany
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Lziwl Gctwlie Hsbkzump Oa Amezre Athens Greece
Hqorzdxc Vdzv dooqoyma Barcelona Spain
Aubstfib Upfbdxrteq Hzgsojpc Lorenskog Norway
Nasdrboz Idnlzxui Oqcsavpzx Iav Msbve Stqcepgberfeobtcihyikbinuyrv Irxpwbyo Biixtsxw Cracow Poland
Uokkxxhvymvkhm Cvxkxte Ksdnyxbgs Gdansk Poland
Mygvgcdqnwuqwjxaigqhlgzuoi Hrtubvsgyixqjvve Halle (Saale) Germany
Iywvvzxa Ciqmih Dhcaxunmyanyrsucv L'hospitalet De Llobregat Spain
Eovefny Mechelen Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
16.06.2024
Czechia Czechia
Recruiting
16.06.2024
Denmark Denmark
Recruiting
16.06.2024
Germany Germany
Recruiting
16.06.2024
Greece Greece
Recruiting
16.06.2024
Norway Norway
Recruiting
16.06.2024
Poland Poland
Recruiting
16.06.2024
Portugal Portugal
Recruiting
16.06.2024
Spain Spain
Recruiting
16.06.2024
Sweden Sweden
Recruiting
16.06.2024

Trial locations

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.

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 ID:
2022-501697-19-01
Protocol code:
MK-1026-011
Trial Phase:
Therapeutic confirmatory (Phase III)

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