Study on the Effectiveness and Safety of Nemtabrutinib for Patients with Blood Cancers, Including CLL, SLL, MCL, MZL, FL, and Waldenström’s Macroglobulinemia

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Nemtabrutinib (also known by its code name MK-1026) in treating certain blood cancers. These cancers include Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Richter’s Transformation, Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), and Waldenström’s Macroglobulinemia (WM). The purpose of the study is to evaluate how effective and safe Nemtabrutinib is for people with these conditions.

Participants in the study will receive Nemtabrutinib in the form of a tablet taken by mouth. The study is divided into two parts. In the first part, the focus is on understanding the safety and how well the body can tolerate Nemtabrutinib. In the second part, the study will look at how well the medication works in treating the different types of blood cancers mentioned. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Nemtabrutinib.

The study will take place over a period of time, with participants being monitored for any side effects and the effectiveness of the treatment. The goal is to gather information that could help improve treatment options for people with these types of blood cancers. Participants will be closely observed by medical professionals throughout the study to ensure their safety and to collect valuable data on the medication’s impact.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Consent will be obtained to ensure understanding and agreement to participate.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests to ensure adequate organ function and overall health status.

3 treatment phase

Participants will begin the treatment phase, receiving the medication nemtabrutinib in the form of a film-coated tablet. The medication is taken orally. The dosage and frequency will be determined by the study protocol and the participant’s specific condition.

During this phase, participants may also receive fludeoxyglucose (18f) as a solution for injection, which is used for imaging purposes to assess the response to treatment.

4 regular monitoring

Participants will attend regular follow-up visits to monitor their health and response to the treatment. This includes physical exams, blood tests, and imaging studies as needed.

The study team will assess any side effects or adverse events experienced during the trial.

5 end of treatment

At the end of the treatment phase, participants will undergo a final assessment to evaluate the overall response to the medication and any lasting effects.

Participants will be informed about the next steps, including any additional follow-up or care required after the trial.

Who Can Join the Study?

  • Must have a confirmed diagnosis of one of the following: Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Richter’s transformation, Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL), Follicular lymphoma (FL), or Waldenström’s macroglobulinemia (WM).
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale used to assess how a disease affects daily living abilities.
  • Must have a life expectancy of at least 3 months.
  • Must be able to swallow and retain oral medication.
  • Must have adequate organ function.
  • For male participants: Must agree to refrain from donating sperm and either remain abstinent or use contraception during the study and for a period after the last dose.
  • For female participants: Must not be pregnant or breastfeeding. If of childbearing potential, must use a highly effective contraceptive method or remain abstinent during the study and for a period after the last dose.
  • Participants with Hepatitis B must have received antiviral therapy for at least 4 weeks and have an undetectable viral load before starting the study.
  • Participants with a history of Hepatitis C must have an undetectable viral load at screening.
  • Participants with HIV must have a CD4 count greater than 350 cells/uL, an undetectable viral load, be on a stable antiretroviral therapy regimen for at least 4 weeks before the study, and be compliant with their therapy.
  • Must have measurable disease, meaning at least one lesion that can be accurately measured in two dimensions using a CT scan.
  • Must have a lymph node biopsy for biomarker analysis, which is a test to look for specific biological markers in the tissue.

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not one of the following: Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Richter’s transformation, Mantle cell lymphoma, Marginal zone lymphoma, Follicular lymphoma, or Waldenström’s macroglobulinemia.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who have an active infection that requires treatment.
  • Patients who have a serious heart condition.
  • Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Hospital Universitario De Salamanca Salamanca Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Orszagos Onkologiai Intezet Budapest Hungary
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
University Hospital Limerick Limerick Ireland
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital General Universitario De Alicante Alicante Spain
University Of Debrecen Debrecen Hungary
Spitalul Clinic Coltea Bucharest Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nice Nice France
Onco Card S.R.L. Brasov Romania
University Of Pecs Pecs Hungary
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universita Degli Studi Di Brescia Brescia Italy
Region Sjaelland Holbæk Denmark
Beaumont Hospital Dublin Ireland
Idryuhcd Crniti Drrboojitsgezzvlj L'hospitalet De Llobregat Spain
Uwrsbguzyt Hnhvsxtq Cqgxozm Cologne Germany
Atoeabboro Pwgnidfs Hhboptvp Dm Pavbc Paris France
Nyujuuvn Iomvhwpv Oextlhjyc Igj Mkrhl Stclvvywtzpsrwyrqmzznknxkodk Icqgyyaq Bwtkxagz Cracow Poland
Afkupjw Uyf Isfse Da Rycukl Ehktfs Reggio Emilia Italy
Avkgdmv Urgxl Szyjavqtz Ldulgb Du Boccxmy Bologna Italy
Hyfzqczx Vuwr dmletxtz Barcelona Spain
Ifdseggs Pwpuangypydighb Cutmij Cnrpwa Marseille France
Hzkrcnal Upkvzcrivznyn dn A Ccgnjy A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
01.06.2021
Denmark Denmark
Recruiting
01.06.2021
France France
Recruiting
01.06.2021
Germany Germany
Recruiting
01.06.2021
Hungary Hungary
Recruiting
01.06.2021
Ireland Ireland
Recruiting
01.06.2021
Italy Italy
Recruiting
01.06.2021
Poland Poland
Recruiting
01.06.2021
Romania Romania
Recruiting
01.06.2021
Spain Spain
Recruiting
01.06.2021

Trial locations

Nemtabrutinib is a medication being studied for its potential to treat various blood cancers. It works by targeting specific proteins in cancer cells, which may help to stop the growth and spread of these cells. The trial aims to determine how safe and tolerable this medication is for patients, as well as to find the most effective dose. Researchers are also looking at how well it works in treating different types of blood cancers, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and others. By participating in this trial, patients may help to advance the understanding of how this medication can be used to treat these serious conditions.

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, infections, and swollen lymph nodes. The disease often remains asymptomatic for years before symptoms appear. As it advances, it can affect the body’s ability to fight infections and may cause anemia or bleeding problems.

Small Lymphocytic Lymphoma – Small Lymphocytic Lymphoma is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to Chronic Lymphocytic Leukemia, with the main difference being the location of the cancer cells. The disease progresses slowly and may not cause symptoms for a long time. When symptoms do occur, they can include swollen lymph nodes, fatigue, and night sweats. The disease can eventually spread to other parts of the body, including the liver and spleen.

Richter’s Transformation – Richter’s Transformation is a condition where Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma transforms into a more aggressive form of lymphoma, usually Diffuse Large B-Cell Lymphoma. This transformation leads to a rapid progression of the disease, with symptoms such as rapidly enlarging lymph nodes, fever, and weight loss. The transformation can occur suddenly and is often associated with a poor response to standard treatments. It represents a significant change in the disease’s behavior and requires different management strategies.

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a rare type of non-Hodgkin lymphoma that arises from B-cells, a type of white blood cell. It typically affects the lymph nodes but can also involve the spleen, bone marrow, and gastrointestinal tract. The disease is characterized by a combination of slow and aggressive growth patterns. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The disease can spread to other parts of the body, complicating its progression.

Marginal Zone Lymphoma – Marginal Zone Lymphoma is a type of slow-growing non-Hodgkin lymphoma that originates from B-cells. It often affects the lymph nodes, spleen, or mucosal-associated lymphoid tissue. The disease progresses slowly, and symptoms may not appear for years. When symptoms do occur, they can include swollen lymph nodes, fatigue, and abdominal discomfort. The disease can spread to other organs over time, affecting their function.

Follicular Lymphoma – Follicular Lymphoma is a common type of indolent non-Hodgkin lymphoma that arises from B-cells. It typically affects the lymph nodes and can spread to the bone marrow and spleen. The disease progresses slowly, often without symptoms for many years. When symptoms develop, they may include painless swollen lymph nodes, fatigue, and night sweats. The disease can transform into a more aggressive form of lymphoma over time.

Waldenström’s Macroglobulinemia – Waldenström’s Macroglobulinemia is a rare type of non-Hodgkin lymphoma characterized by the overproduction of a protein called immunoglobulin M (IgM). This condition affects the bone marrow and can lead to symptoms such as fatigue, bleeding, and vision problems. The disease progresses slowly, and symptoms may not appear for a long time. As it advances, it can cause complications such as anemia and hyperviscosity syndrome, where the blood becomes too thick. The disease can also affect the nervous system and other organs.

Trial ID:
2023-504931-42-00
Protocol code:
MK-1026-003
Trial Phase:
Therapeutic exploratory (Phase II)

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