← Back to Search

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:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

CLOVER-WaM Trial 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.

CLOVER-WaM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with CNS lymphoma.

Select...

My cancer is getting worse.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

I need immediate treatment for Waldenstrom's macroglobulinemia.

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

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

Select...

My blood cancer has changed into a more aggressive type.

Select...

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

Select...

I have undergone at least one treatment regimen before.

Select...

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

Select...

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

Select...

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

CLOVER-WaM Trial 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

CLOVER-WaM 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 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cellectar Biosciences, Inc.Lead Sponsor

14 Previous Clinical Trials

1,145 Total Patients Enrolled

John Friend, MDStudy DirectorCellectar Biosciences

1 Previous Clinical Trials

30 Total Patients Enrolled

Jarrod LongcorStudy DirectorCellectar Biosciences

2 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

CLR 131 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02952508 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Iopofosine I 131, intravenous administration MM, Iopofosine I 131, intravenous administration CNS Lymphoma, Iopofosine I 131 intravenous administration NHL [CLOSED], Iopofosine I 131, intravenous administration WM

Non-Hodgkin's Lymphoma Clinical Trial 2023: CLR 131 Highlights & Side Effects. Trial Name: NCT02952508 — Phase 2

CLR 131 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02952508 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this clinical investigation?

"To begin the medical trial, Cellectar Biosciences, Inc. requires 120 participants who meet its inclusion criteria. The experiment will be hosted in multiple locations such as the Buffalo and New york branches of Cellectar Biosciences."

Answered by AI

What negative effects does long-term use of Iopofosine I 131 have on individuals?

"Given the Phase 2 nature of this trial, with some safety data but none for efficacy, Iopofosine I 131 multiple dose has been assigned a score of 2."

Answered by AI

Could you please provide an overview of the prior testing that has been done on Iopofosine I 131 multiple dose?

"At the present moment, three trials are running to assess Iopofosine I 131 multiple dose. None of them have made it past Phase 3 yet; however, 33 different medical centres in Redlands California and beyond are taking part in these studies."

Answered by AI

How widely is this research experiment being conducted?

"As of now, 14 clinical trial sites are registering participants. These locations range from Buffalo to Cincinnati and other cities across the US. Prospective enrollees should pick a nearby facility so that they can minimize travel-related hassles."

Answered by AI

Is this trial still open to recruitment?

"Clinicaltrials.gov shows that this experiment is actively enrolling volunteers and has been since July 26th 2017. The latest edit was made on August 11th 2022."

Answered by AI

What is the intended result of this research?

"According to information disclosed by the sponsor of this trial, Cellectar Biosciences Inc., their primary outcome measure over a 84 day period will be Part B [CLOVER-WaM] Major Response Rate. To supplement this data, they are additionally evaluating secondary outcomes such as Part A [CLOVER-1] Overall Response Rate (as defined by International Uniform Response Criteria for Multiple myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic lymphocytic leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Crit"

Answered by AI

Is this clinical experiment a pioneering venture?

"Currently, Cellectar Biosciences, Inc. has 3 open studies for Iopofosine I 131's multiple dose across 24 cities and 6 countries. Since the initial study in 2017 which involved 120 participants and cleared Phase 2 drug approval stages, two additional trials have been launched."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02952508.

All > South Carolina > Kansas