Iopofosine for Waldenstrom Macroglobulinemia

(CLOVER-WaM Trial)

Recruiting at 49 trial locations

Overseen By Kate Oliver

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cellectar Biosciences, Inc.

Must not be taking: Antiplatelet therapy

Disqualifiers: Chronic immunosuppressive therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop any anti-cancer therapy at least two weeks before starting the study treatment. However, low-dose dexamethasone for symptom management is allowed. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

What is the purpose of this trial?

This trial is testing a special radiation treatment called iopofosine I 131 in patients with hard-to-treat B-cell cancers. These patients have not responded well to other treatments. The treatment works by using a radioactive substance that targets and kills cancer cells.

Research Team

Jarrod Longcor

Principal Investigator

Cellectar Biosciences

Eligibility Criteria

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.

Inclusion Criteria

I have a tumor larger than 15mm or a liver nodule bigger than 10mm.

I have side effects from past treatments, but they are manageable.

I have been diagnosed with CNS lymphoma.

Exclusion Criteria

I have had full or half-body radiation before, but may still qualify based on specific conditions.

I have a history of cancer.

I haven't had cancer in the last 5 years, except for skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive iopofosine I 131 intravenously for the treatment of relapsed or refractory B-cell malignancies

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

135 days

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• CLR 131
• Iopofosine I 131

Trial Overview 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.

Participant Groups

Group I: Iopofosine I 131, intravenous administration WM Experimental Treatment 3 Interventions

Iopofosine I 131 in Waldenstroms Macroglobulinemia

Group II: Iopofosine I 131, intravenous administration MM Experimental Treatment 3 Interventions

Iopofosine I 131 in Multiple Myeloma

Group III: Iopofosine I 131, intravenous administration CNS Lymphoma Experimental Treatment 1 Intervention

Iopofosine I 131 in Central Nervous System Lymphoma

Group IV: Iopofosine I 131 intravenous administration NHL [CLOSED] Experimental Treatment 3 Interventions

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

CLR 131 is already approved in United States, European Union for the following indications:

Approved in United States as Iopofosine I-131 for:

• Relapsed or refractory multiple myeloma
• Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia
• Diffuse large B-cell lymphoma

Approved in European Union as Iopofosine I-131 for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

Cellectar Biosciences, Inc.

Lead Sponsor

Trials

15

Recruited

1,300+