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Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom

This research study, called CLOVER-1, is exploring a new medicine called Iopofosine I-131 for individuals living with specific types of B-cell cancers. These include conditions like Waldenstrom's macroglobulinemia, multiple myeloma, and various lymphomas, particularly when standard treatments haven't worked or have stopped working. The study is divided into two parts: Part A is generally looking at the drug's effect across several B-cell cancers, while Part B is focusing specifically on Waldenstrom's macroglobulinemia patients who have had at least two previous treatments. The new medicine is designed to specifically target and treat cancer cells, and researchers want to find out how safe and helpful it can be for patients.

At a glance

What is this study about?

This study is investigating a new treatment called Iopofosine I-131 for a group of conditions known as B-cell cancers. These cancers, which include types like Waldenstrom's macroglobulinemia, multiple myeloma, and various lymphomas, can be very challenging to treat, especially when they come back after initial treatments or don't respond well to standard care. For many patients, finding effective new options is extremely important, as existing treatments may eventually stop working.

Iopofosine I-131 is a special type of medicine known as a 'targeted radiotherapeutic'. This means it's designed to specifically find and attack cancer cells in the body. It does this by using a drug that cancer cells tend to absorb, which is then combined with a small amount of radiation (known as iodine-131). Once inside the cancer cells, the radiation can help to destroy them. This approach has shown promise in laboratory tests and is now being studied in people.

Researchers are particularly interested in seeing how effective this treatment is for patients whose cancers have not responded to previous therapies. The study aims to gather more information about how this medicine works, its potential benefits, and any side effects it might have. This could eventually lead to a new treatment option for people living with these challenging B-cell cancers.

Key takeaways

  • New study for B-cell cancers (e.g., Waldenstrom, myeloma, lymphoma).
  • Investigates Iopofosine I-131, a targeted new treatment.
  • Aimed at patients whose cancers haven't responded to standard treatments.
  • This treatment specifically targets and aims to destroy cancer cells.
  • Close monitoring for safety and effectiveness is a key part of the study.

Who may be eligible?

To join this study, participants must be at least 18 years old and generally in good health, with an expected lifespan of at least six months. Your body should be able to make enough blood cells (like platelets and white blood cells), and your kidneys and liver should be working fairly well.

Specifically for patients with multiple myeloma, you would need to have tried at least five different treatments before, including specific types of drugs such as proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies. Your multiple myeloma would also need to have grown or not responded to these previous treatments. You might also be eligible if you have certain other B-cell cancers and have had prior treatments.

The study team will carefully review your medical history and test results to see if this study is right for you. They will explain all the requirements in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you generally feeling well with good energy levels?
  3. Do you have good kidney and liver function?
  4. If you have multiple myeloma, have you tried many previous treatments that didn't work well?
  5. Have you not had a stem cell transplant in the last 100 days?
Answer every question to see your result.

What does participation involve?

The information provided does not give specific details about the number of hospital visits, duration of treatment, or follow-up schedule. However, based on the type of intervention (single, multiple, or fractionated doses of a targeted radiotherapeutic), it's likely that participation would involve:

* **Initial screening:** A series of tests and checks to confirm eligibility. * **Treatment administration:** Receiving the Iopofosine I-131 medicine intravenously (into a vein). The study mentions single, multiple, or fractionated doses, which means you might receive the treatment once, several times, or in smaller amounts over a period. * **Monitoring:** Regular check-ups, blood tests, and scans to monitor your health, how you're responding to the treatment, and any side effects. * **Follow-up:** Continued observation after the treatment period to track your long-term health and the lasting effects of the medication. The total duration of participation and specific schedule would be fully explained by the study team.

Potential risks and benefits

Participating in any clinical trial involves both potential benefits and risks. The potential benefit of this study is that you might gain access to a new treatment that could help control your cancer, especially if other treatments haven't worked for you. This could potentially improve your health and quality of life. However, like all medicines, Iopofosine I-131 could have side effects, which might range from mild to serious, and it may not be effective for everyone. As with any new treatment, some risks may not yet be known. You would be closely monitored throughout the study, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (52)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cellectar Biosciences site
    Verified postcode
    Los Angeles, United States
  • Cellectar Biosciences site
    Verified postcode
    Redlands, United States
  • Cellectar Biosciences site
    Verified postcode
    Washington D.C., United States
  • Cellectar Biosciences site
    Verified postcode
    Jacksonville, United States
  • Cellectar Biosciences site
    Verified postcode
    Miami, United States
  • Cellectar Biosciences site
    Verified postcode
    Tampa, United States
  • Cellectar Biosciences
    Verified postcode
    Atlanta, United States
  • Cellectar Biosciences site
    Verified postcode
    Maywood, United States
  • Cellectar Biosciences site
    Verified postcode
    Warrenville, United States
  • Cellectar Biosciences site
    Verified postcode
    Westwood, United States
  • Cellectar Biosciences site
    Verified postcode
    New Orleans, United States
  • Cellectar Biosciences site
    Verified postcode
    Baltimore, United States

Common questions

What kind of cancers is this study for?

This study is for specific B-cell cancers like Waldenstrom's macroglobulinemia, multiple myeloma, and different types of lymphoma, especially if you've already had other treatments that didn't work.

What is Iopofosine I-131 and how does it work?

It's a new treatment that uses a special drug combined with a small amount of radiation. This combination is designed to find and destroy cancer cells specifically.

Has this treatment been used before?

While this specific drug is new, the radiation component (iodine-131) has been approved and used in other cancer treatments before. The combined drug has also shown promise in lab studies.

Will I have to stay in hospital?

The information doesn't specify. You will receive the treatment into a vein, and you'll have regular check-ups. The study team will tell you if any hospital stays are needed for treatment or monitoring.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, without affecting your normal medical care or relationship with your healthcare providers.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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