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

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What is this study about?

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.

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).

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Ixmnckia Cmqhvw Dusxqrbkximmlkkil L'hospitalet De Llobregat Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
08.06.2022
Greece Greece
Not recruiting
08.06.2022
Spain Spain
Not recruiting
08.06.2022

Trial locations

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.

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.

Trial ID:
2023-508671-37-00
Protocol code:
DCL-16-001
NCT ID:
NCT02952508
Trial Phase:
Therapeutic exploratory (Phase II)

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