RecruitingRare disease

Study on Zanubrutinib and Rituximab for Patients with IgM Monoclonal Gammopathy and MAG Antibodies-Related Polyneuropathy

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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 a condition known as IgM monoclonal gammopathy of unknown significance (MGUS) and its related nerve disorder, myelin associated glycoprotein (MAG) antibodies associated polyneuropathy. These conditions can affect the nerves, leading to symptoms like weakness and numbness. The study is exploring the use of a medication called Zanubrutinib, which is taken as a hard capsule, in combination with another treatment called Rituximab. The aim is to see if this combination can improve nerve function in patients over a period of 12 months.

Participants in the study will receive the treatment and be monitored for any changes in their condition. The study will last for up to 36 months, during which time the safety and tolerability of the treatment will also be assessed. The researchers are interested in understanding how well patients adhere to the treatment and any side effects that may occur. The study will also track improvements in the ability to perform daily activities and overall quality of life.

The trial will measure various outcomes, including changes in nerve function and overall health, using specific scoring systems designed to assess disability and quality of life. The study will also look at how the treatment affects certain blood markers and the presence of specific antibodies. This research aims to provide valuable insights into the potential benefits of Zanubrutinib and Rituximab for patients with these nerve-related conditions.

The research process

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

Step 1
Initiation of treatment
Upon joining the study, the treatment begins with the administration of zanubrutinib and rituximab. Zanubrutinib is provided in the form of 80 mg hard capsules, taken orally.
The dosage and frequency of zanubrutinib are determined by the study protocol, and it is important to follow the instructions provided by the healthcare team.
Step 2
Treatment cycles
The treatment is organized into cycles, each lasting a specific duration as outlined in the study protocol. The primary goal is to assess improvement in neurological outcomes after 12 months.
During each cycle, the patient's response to the treatment is monitored, and any necessary dose adjustments are made based on individual tolerance and response.
Step 3
Monitoring and assessments
Throughout the study, regular assessments are conducted to evaluate the patient's condition. This includes monitoring for any adverse events and measuring the effectiveness of the treatment using various scales and tests.
Key assessments include the Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, hematological response rates, and quality of life evaluations.
Step 4
Follow-up period
After completing the treatment cycles, a follow-up period is conducted to observe long-term effects and any changes in the patient's condition.
During this time, additional assessments are performed at specified intervals to track the progression of the disease and the sustainability of the treatment benefits.
Step 5
End of study
The study concludes with a final evaluation of the patient's overall health and response to the treatment. This includes a comprehensive review of all collected data and outcomes.
The estimated end date for the study is November 1, 2027, marking the completion of all follow-up activities and data analysis.

Who can join the trial?

12 criteria

Must be able to provide written consent and understand the study requirements.
No history of severe bleeding disorders like hemophilia or spontaneous bleeding that needed medical treatment.
Previous treatment with intravenous immunoglobulins is allowed if it was more than 3 months ago.
Previous treatment for nerve issues with certain medications is allowed if it was more than 6 months ago. If Rituximab was used and didn't work more than 6 months ago, you can still join.
Must have a type of nerve problem called demyelinating polyneuropathy, as defined by specific medical guidelines. This means the protective covering of the nerves is damaged.
Must have some level of difficulty in daily activities, measured by a specific disability score of 2 or more.
Must be 18 years or older.
Must have a condition called IgM monoclonal gammopathy of unknown significance (MGUS), which means having a certain protein in the blood that is detectable but less than 30 g/L, along with high total IgM levels.
Must have a certain level of anti-MAG antibodies in the blood, measured as 10,000 or more units.
Must have a performance score of 0, 1, or 2 on a scale that measures daily activity ability, called the Eastern Cooperative Oncology Group (ECOG) performance score.
Must have adequate blood health, with hemoglobin levels of 6.0 mmol/L or more, neutrophils over 1.0 x 10^9/L, and platelets over 100 x 10^9/L.
Must have adequate liver and kidney function, with specific lab values for liver enzymes, bilirubin, and creatinine clearance.

Who cannot join the trial?

13 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are currently participating in another clinical trial.
Patients who have allergies or reactions to the study medications.
Patients who have a history of certain types of cancer.
Patients who have a history of drug or alcohol abuse.
Patients who have certain heart conditions.
Patients who have liver or kidney problems.
Patients who have a history of blood disorders.
Patients who have a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have had a recent surgery or are planning to have surgery during the study.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

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Investigated drugs

Zanubrutinib
is a medication being studied for its potential to improve neurological outcomes in patients with a specific type of nerve disorder related to abnormal protein levels in the blood. It is being tested to see if it can help reduce symptoms and improve the quality of life for these patients.
Rituximab
is a standard therapy used in this study alongside Zanubrutinib. It is commonly used to treat certain immune system disorders and works by targeting specific cells in the body. The study aims to see if combining Rituximab with Zanubrutinib can provide better results for patients with this nerve disorder.

Zanubrutinib

What is already known about the treatment

Zanubrutinib
Zanubrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its potential benefits in treating certain neurological conditions. The main therapeutic indication for Zanubrutinib in this trial is for patients with IgM monoclonal gammopathy of unknown significance (MGUS) and myelin-associated glycoprotein (MAG) antibodies associated polyneuropathy. At the molecular level, Zanubrutinib works by inhibiting Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of certain immune cells. It is classified as a BTK inhibitor.
Rituximab
Rituximab is administered through intravenous infusion. It is a well-established medication used in the treatment of various autoimmune diseases and certain types of cancer. In this clinical trial, Rituximab is used in combination with Zanubrutinib to potentially improve neurological outcomes in patients with IgM monoclonal gammopathy of unknown significance (MGUS) and MAG antibodies associated polyneuropathy. Rituximab works by targeting and depleting CD20-positive B cells, which are involved in the immune response. It is classified as a monoclonal antibody.

Investigated diseases

IgM Monoclonal Gammopathy of Unknown Significance (MGUS)
This condition is characterized by the presence of an abnormal protein in the blood, known as monoclonal protein or M protein, produced by a small number of plasma cells. It is generally asymptomatic and often discovered incidentally during blood tests for other conditions. Over time, MGUS can remain stable or progress to more serious disorders, such as multiple myeloma or lymphoma. The progression is typically slow, and many individuals with MGUS never experience any related health issues. Regular monitoring is usually recommended to track any changes in the condition.
Myelin Associated Glycoprotein (MAG) Antibodies Associated Polyneuropathy
This is a rare neurological disorder where the immune system mistakenly attacks the peripheral nerves, leading to damage. The condition is associated with the presence of antibodies against myelin-associated glycoprotein, which is crucial for nerve function. Symptoms often include numbness, tingling, and weakness, primarily in the legs and arms. The progression of the disease can vary, with some individuals experiencing a slow worsening of symptoms over time. The condition can impact daily activities, depending on the severity of nerve damage.