Study of Iopofosine I 131 (CLR 131) for Certain B-Cell Blood Cancers and Waldenstrom Macroglobulinemia
Sponsor: Cellectar Biosciences, Inc.
ClinicalTrials ID:NCT02952508
This clinical trial is testing a new treatment called iopofosine I 131 (CLR 131) for patients with certain B-cell blood cancers, including Waldenstrom Macroglobulinemia, who have already tried other treatments.
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Program Overview
This study is exploring the use of iopofosine I 131, a new type of treatment that targets cancer cells, in patients with specific B-cell blood cancers. These include multiple myeloma, chronic lymphocytic leukemia, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, Waldenstrom Macroglobulinemia, marginal zone lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, and central nervous system lymphoma. The study is particularly focused on patients whose cancer has not responded to standard treatments. Part of the study is specifically looking at how well this treatment works in patients with Waldenstrom Macroglobulinemia who have already tried at least two other treatments.
Description
B-cell blood cancers are a group of diseases that affect the blood and lymphatic system. They can be difficult to treat, especially when they come back or don't respond to standard treatments. Iopofosine I 131 is a new treatment that uses a radioactive substance to target and kill cancer cells. It has been tested in many laboratory models and has shown promise in reducing tumors.
This study aims to find out if iopofosine I 131 can be an effective treatment for patients with these types of cancers, especially those who have not had success with other treatments. The study is divided into two parts: one part includes various B-cell cancers, and the other focuses on Waldenstrom Macroglobulinemia. Researchers hope this treatment will offer a new option for patients with these challenging conditions.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of one of the specific B-cell blood cancers listed in the study.
- Must be 18 years or older.
- Must have a life expectancy of at least 6 months.
- Must have certain blood counts and organ functions within specified limits.
- Must have tried previous treatments for their cancer.
- For multiple myeloma patients, must have tried at least five different treatments, including specific types of drugs.
- For Waldenstrom Macroglobulinemia patients, must have tried at least two previous treatments.
- Must have measurable disease, meaning the cancer can be tracked using tests or scans.
Exclusion Criteria
- Cannot have ongoing severe side effects from previous treatments.
- Cannot have had certain types of radiation therapy that affect a large portion of the bone marrow.
- Cannot have tumors pressing on the spinal cord.
- Cannot be on ongoing immunosuppressive therapy.
- Cannot have had a significant bleeding event in the past 6 months.
- Cannot have had other cancer treatments within two weeks before starting the study treatment.
- For Waldenstrom Macroglobulinemia patients, cannot have another active cancer that requires treatment.
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