Not recruitingRare disease

Study of CLR 131 for Patients with Relapsed or Refractory Waldenstrom Macroglobulinemia

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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 the effects of a treatment called CLR 131 in patients with certain types of blood cancers known as B-Cell malignancies. Specifically, the study is looking at patients with a condition called Waldenstrom Macroglobulinemia, which is a rare type of cancer that affects white blood cells. The treatment being tested, CLR 131, is a sterile solution that is given through an intravenous infusion, meaning it is administered directly into the bloodstream. The study also involves the use of another medication, Potassium Iodide, which is taken orally.

The purpose of this study is to evaluate how well CLR 131 works in patients who have already tried at least two other treatments for their condition. Participants in the study will receive the treatment and be monitored over a period of time to see how their cancer responds. The study will look at various outcomes, such as how many patients experience a significant reduction in their cancer, how long they remain free from needing further treatment, and the overall safety of the treatment.

Throughout the study, patients will undergo regular assessments to track their response to the treatment and any side effects they may experience. These assessments will include checking vital signs, performing laboratory tests, and possibly conducting electrocardiograms (ECGs) to monitor heart health. The study aims to provide valuable information on the effectiveness and safety of CLR 131 for patients with Waldenstrom Macroglobulinemia and other B-Cell malignancies.

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
Initial assessment
The patient undergoes an initial assessment to confirm eligibility for the study. This includes verifying a diagnosis of Waldenstrom Macroglobulinemia (WM) and ensuring the patient has received at least two prior lines of therapy.
The patient's performance status is evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, which ranges from 0 (fully active) to 2 (capable of self-care but unable to carry out any work activities).
Step 2
Treatment initiation
The patient begins treatment with CLR 131, administered through an intravenous infusion. The specific dosage and frequency are determined by the study protocol.
In addition to CLR 131, the patient may receive potassium iodide orally as a supportive medication.
Step 3
Treatment monitoring
The patient is monitored for response to treatment and any side effects. This includes regular assessments of vital signs, laboratory tests, and electrocardiograms (ECGs).
The patient's response to treatment is evaluated using criteria modified from the VIth Waldenstrom’s Macroglobulinemia Criteria for Response Assessment.
Step 4
Follow-up assessments
The patient undergoes follow-up assessments to determine the duration of response and overall response rate. These assessments continue for up to 12 months after the first infusion of CLR 131.
The study also evaluates treatment-free survival, which is the time from the last CLR 131 dose to the initiation of subsequent therapy or death.
Step 5
Safety evaluations
Throughout the study, the patient is monitored for safety, including any adverse events or serious adverse events. The severity of these events is graded, and the patient's ECOG performance status is regularly assessed.

Who can join the trial?

5 criteria

The patient must have a confirmed diagnosis of **Waldenstrom Macroglobulinemia (WM)**. This can be confirmed through specific tests that look at the cells in the body. Patients with a similar condition called **LPL** may also join if approved by the study organizers.
The patient should have an **ECOG performance status** between 0 and 2. This is a scale that helps doctors understand how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half the day but may not be able to work.
The patient must be **18 years of age or older**.
The patient should have a **life expectancy** of at least 6 months, meaning they are expected to live for at least this amount of time.
The patient must have received **at least two prior lines of therapy** for WM. This means they have tried at least two different treatment plans before.

Who cannot join the trial?

5 criteria

Patients who have not received at least two previous treatments for their condition.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Alexandra Hospital
Athens, Greece
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
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Centre Hospitalier Universitaire De Poitiers
Poitiers, France

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Investigated drugs

CLR 131 is a medication being studied for its effectiveness in treating certain types of blood cancers, specifically B-cell malignancies. It is being tested in patients whose cancer has returned or has not responded to previous treatments. The main goal of the study is to see how well CLR 131 works in patients with Waldenstrom Macroglobulinemia, a type of B-cell cancer, who have already tried at least two other treatments.

What is already known about the treatment

CLR 131 – CLR 131 is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Waldenstrom Macroglobulinemia, a type of B-cell malignancy. The medication is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. It is primarily indicated for patients with relapsed or refractory Waldenstrom Macroglobulinemia who have undergone at least two prior treatments. CLR 131 works by delivering a radioactive isotope directly to cancer cells, which helps to destroy them while minimizing damage to surrounding healthy tissue. It is classified as a radiopharmaceutical, a type of drug that combines a radioactive element with a pharmaceutical agent.

Investigated diseases

Waldenstrom Macroglobulinemia – This is a rare type of non-Hodgkin lymphoma characterized by an overproduction of abnormal white blood cells called lymphoplasmacytic cells. These cells accumulate in the bone marrow, lymph nodes, and spleen, leading to various symptoms. As the disease progresses, it can cause anemia, fatigue, and bleeding due to the crowding out of normal blood cells. Patients may also experience hyperviscosity syndrome, where the blood becomes too thick, leading to vision problems, headaches, and dizziness. The disease typically progresses slowly, and symptoms can vary widely among individuals.