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Iopofosine for Waldenstrom Macroglobulinemia (CLOVER-WaM Trial)
CLOVER-WaM Trial Summary
This trial is testing the effectiveness of iopofosine I 131 in treating patients with various types of B-cell malignancies.
CLOVER-WaM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCLOVER-WaM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CLOVER-WaM Trial Design
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Who is running the clinical trial?
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- 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.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.My cancer diagnosis was confirmed through lab tests.You have a sufficient amount of a type of white blood cell called neutrophils in your blood.You have a disease that can be measured to track changes.My cancer is getting worse.I have had one treatment for H. pylori for my stomach lymphoma.I haven't had cancer treatments like radiation or chemotherapy in the last 2 weeks.I have brain lymphoma with no active bleeding or uncontrolled seizures.I have undergone at least two treatments for Waldenstrom's macroglobulinemia.I am on anti-platelet medication, but not just low-dose aspirin for heart protection.I haven't had cancer treatment in the last 2 weeks, except for low dose dexamethasone.I am 18 years old or older.I have side effects from past treatments, but not hair loss.I haven't had cancer treatment in the last 2 weeks.I need immediate treatment for Waldenstrom's macroglobulinemia.My hemoglobin level is at least 9 g/dL and I haven't had a blood transfusion in the last week.My kidney function is at a safe level for the trial.My blood thinner medication can be safely stopped if needed.I have undergone at least 2 treatment regimens for my condition.I can care for myself and am up and about more than half of my waking hours.I am 18 years old or older.I've had 5 or more treatments for my condition, including specific cancer drugs.My condition hasn't improved after treatments with three specific drug types.I have not had any serious bleeding in the last 6 months.My DLBCL cancer did not respond well to treatment with rituximab and an anthracycline.I have another cancer besides WM, but it's either in remission, treated successfully if it was skin or prostate cancer, or hasn't needed treatment in the last 2 years.I am on long-term medication to suppress my immune system.Your bilirubin levels are lower than 1.5 times the upper limit of normal.My blood cancer has changed into a more aggressive type.My tumor is near the spinal cord and might swell with treatment.Your platelet count should be at least 75,000/µL, and if you are on strong blood thinning medication, it should be at least 100,000/µL.Your white blood cell count is at least 3000 per microliter.I have undergone at least one treatment regimen before.You have high levels of IgM in your blood or specific-sized nodal or extranodal lesions.Your AST and ALT levels are not more than 2.5 times the upper limit of normal.I can take care of myself and am up and about more than half of my waking hours.You are expected to live for at least 6 months.Your blood clotting test (INR) should be less than 2.5.More than 20% of my bone marrow received over 20 Gy from radiation therapy.I had a stem cell transplant more than 100 days ago.I have had a condition where my lymphocytes grow abnormally.
- Group 1: Iopofosine I 131, intravenous administration MM
- Group 2: Iopofosine I 131, intravenous administration CNS Lymphoma
- Group 3: Iopofosine I 131 intravenous administration NHL [CLOSED]
- Group 4: Iopofosine I 131, intravenous administration WM
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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"
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."
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