Iopofosine for Waldenstrom Macroglobulinemia
(CLOVER-WaM Trial)

Recruiting in Palo Alto (17 mi)

+49 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cellectar Biosciences, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

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.

See 39 more

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.

See 2 more

Treatment Details

Interventions

CLR 131 (Radioisotope Therapy)
Iopofosine I 131 (Radioisotope Therapy)

Trial OverviewThe 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

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