What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as radioimmunotherapy (e.g., Iodine-131 labeled antibodies like Iopofosine I 131), often result in side effects including cytopenias (low blood cell counts), fatigue, nausea, and potential radiation-related effects like thyroid dysfunction. Other targeted therapies, such as monoclonal antibodies (e.g., rituximab), can cause infusion reactions, infections, and mild alopecia. Chemotherapy regimens may lead to more severe side effects, including myelosuppression, gastrointestinal disturbances, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) that involve targeted radiotherapy using radioisotopes. One notable example is Yttrium-90 ibritumomab tiuxetan (Zevalin), a radioimmunotherapy that combines a monoclonal antibody with the radioisotope Yttrium-90 to target and destroy cancer cells. Another similar treatment is Iodine-131 tositumomab (Bexxar), which also uses a monoclonal antibody conjugated with Iodine-131 for targeted radiotherapy. These therapies leverage the ability of radioisotopes to deliver radiation directly to cancer cells, minimizing damage to surrounding healthy tissue.

What other types of research exist?

Promising novel alternatives to Iopofosine I 131 for Non-Hodgkin's Lymphoma patients include: 1) CAR T-cell therapies (e.g., axicabtagene ciloleucel, tisagenlecleucel), which have shown significant efficacy in relapsed or refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 on B-cells and engage T-cells to kill cancer cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Novel BTK inhibitors (e.g., zanubrutinib, acalabrutinib) that offer targeted inhibition of B-cell receptor signaling pathways. These therapies represent significant advancements in the treatment landscape for NHL.

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Radioisotope Therapy

Iopofosine for Waldenstrom Macroglobulinemia (CLOVER-WaM Trial)

Phase 2

Recruiting

Research Sponsored by Cellectar Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with CNS Lymphoma

Progressive disease defined by any of the following:

Must not have

History of active malignancy

History of any lymphoproliferative disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Summary

This trial is testing the effectiveness of iopofosine I 131 in treating patients with various types of B-cell malignancies.

Who is the study for?

This trial is for adults with certain B-cell malignancies like multiple myeloma, CLL/SLL, and Waldenstrom Macroglobulinemia who have had previous treatments. They should be in a stable condition with adequate organ function and blood counts. People can't join if they've recently had other cancer therapies, significant radiation to the bone marrow, uncontrolled side effects from past treatments (except hair loss), or are dealing with another active cancer.Check my eligibility

What is being tested?

The study tests Iopofosine I 131 at different doses in patients with select B-cell cancers. Part A looks at previously treated patients while Part B focuses on those with Waldenstrom Macroglobulinemia after two prior therapies. The drug's given through an IV and aims to see how well it works against these cancers.See study design

What are the potential side effects?

Possible side effects of Iopofosine I 131 include nausea, fatigue, lowered blood cell counts leading to increased infection risk or bleeding problems, potential kidney or liver issues due to the drug's toxicity, and allergic reactions during infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CNS lymphoma.

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My cancer is getting worse.

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I have had one treatment for H. pylori for my stomach lymphoma.

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My DLBCL cancer did not respond well to treatment with rituximab and an anthracycline.

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I have brain lymphoma with no active bleeding or uncontrolled seizures.

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I have undergone at least two treatments for Waldenstrom's macroglobulinemia.

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I have not had any serious bleeding in the last 6 months.

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I am 18 years old or older.

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I have side effects from past treatments, but not hair loss.

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I need immediate treatment for Waldenstrom's macroglobulinemia.

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I can care for myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My kidney function is at a safe level for the trial.

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My condition hasn't improved after treatments with three specific drug types.

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I am on long-term medication to suppress my immune system.

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My blood cancer has changed into a more aggressive type.

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My tumor is near the spinal cord and might swell with treatment.

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I have undergone at least one treatment regimen before.

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I can take care of myself and am up and about more than half of my waking hours.

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More than 20% of my bone marrow received over 20 Gy from radiation therapy.

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I had a stem cell transplant more than 100 days ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer.

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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A [CLOVER-1] Clinical benefit rate

Part B [CLOVER-WaM] Major Response Rate

Secondary outcome measures

Part A [CLOVER-1] Duration of Response

Part A [CLOVER-1] Overall Response Rate

Part A [CLOVER-1] Overall Survival

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Iopofosine I 131, intravenous administration WMExperimental Treatment3 Interventions

Iopofosine I 131 in Waldenstroms Macroglobulinemia

Group II: Iopofosine I 131, intravenous administration MMExperimental Treatment3 Interventions

Iopofosine I 131 in Multiple Myeloma

Group III: Iopofosine I 131, intravenous administration CNS LymphomaExperimental Treatment1 Intervention

Iopofosine I 131 in Central Nervous System Lymphoma

Group IV: Iopofosine I 131 intravenous administration NHL [CLOSED]Experimental Treatment3 Interventions

Iopofosine I 131 in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma

0 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include targeted radiotherapy, such as Iopofosine I 131 (CLR 131), which uses the radioactive isotope Iodine-131 to deliver radiation directly to cancer cells. This targeted approach allows for the destruction of cancer cells while sparing healthy tissue, potentially reducing side effects and improving patient outcomes. This precision in targeting cancer cells is crucial for NHL patients, as it offers a more effective and less toxic treatment option compared to conventional therapies.