Iopofosine for Waldenstrom Macroglobulinemia
(CLOVER-WaM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called iopofosine I 131 for certain types of blood cancer, specifically targeting Waldenstrom Macroglobulinemia (WM). The goal is to determine if iopofosine I 131 can benefit patients whose cancer has returned or not improved after other treatments. Suitable candidates have WM and have tried at least two different treatments but still exhibit symptoms or measurable signs of the disease. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that iopofosine I 131 is likely to be safe for humans?
Research has shown that iopofosine I 131 has been tested for safety in patients with various B-cell cancers. In studies where patients received multiple doses, researchers used a standard system to track side effects. Although specific data from those studies is not provided here, the FDA has granted iopofosine I 131 "breakthrough therapy designation." This status indicates it could offer significant benefits over current treatments, particularly for individuals with relapsed or hard-to-treat Waldenström Macroglobulinemia. However, like any medical treatment, it can have side effects, so participants should discuss potential risks with their healthcare provider.12345
Why do researchers think this study treatment might be promising for Waldenstrom Macroglobulinemia?
Unlike the standard treatments for Waldenstrom Macroglobulinemia, which often include chemotherapy and monoclonal antibodies, Iopofosine I 131 introduces a novel approach by using a radioactive isotope. This treatment uniquely delivers radiation directly to the cancer cells, potentially sparing more healthy tissue than traditional methods. Researchers are excited about Iopofosine I 131 because it targets the cancer at a cellular level, which could lead to more effective and precise treatment outcomes with potentially fewer side effects.
What evidence suggests that iopofosine I 131 could be an effective treatment for Waldenstrom Macroglobulinemia?
Research has shown that Iopofosine I 131 holds promise for treating Waldenstrom Macroglobulinemia (WM). In studies with patients who had tried other treatments, Iopofosine I 131 achieved an impressive 83.6% overall response rate, indicating that most patients experienced some improvement. Additionally, the clinical benefit rate reached 98.2%, showing that nearly all patients experienced positive effects. Participants in this trial will receive Iopofosine I 131, which the FDA has recognized for its potential by granting it a breakthrough designation, highlighting its effectiveness for patients with relapsed or hard-to-treat WM.12456
Who Is on the Research Team?
Jarrod Longcor
Principal Investigator
Cellectar Biosciences
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive iopofosine I 131 intravenously for the treatment of relapsed or refractory B-cell malignancies
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Iopofosine I 131 in Waldenstroms Macroglobulinemia
Iopofosine I 131 in Multiple Myeloma
Iopofosine I 131 in Central Nervous System Lymphoma
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:
- Relapsed or refractory multiple myeloma
- Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia
- Diffuse large B-cell lymphoma
- Relapsed or refractory multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cellectar Biosciences, Inc.
Lead Sponsor
Citations
1.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/861/530752/Iopofosine-I-131-in-Previously-Treated-PatientsIopofosine I 131 in Previously Treated Patients with ...
Conclusion: Iopofosine I 131 demonstrated durable efficacy in previously treated WM patients, with no current standard of care therapy. The ...
2.
onclive.com
onclive.com/view/iopofosine-i-131-is-efficacious-tolerable-in-heavily-pretreated-r-r-waldenstr-m-macroglobulinemiaIopofosine I 131 Is Efficacious, Tolerable in Heavily ...
Iopofosine I 131 achieved an 83.6% overall response rate and 98.2% clinical benefit rate in relapsed/refractory Waldenström macroglobulinemia ...
NCT02952508 | Study of Iopofosine I 131 (CLR 131) in ...
Iopofosine I 131 has been evaluated in over 80 xenograft and spontaneous (transgenic) tumor models where it was demonstrated to be effective in eliminating ...
Iopofosine I 131 in Previously Treated Patients with ...
Iopofosine I 131 demonstrated durable efficacy in previously treated WM patients, with no current standard of care therapy.
5.
onclive.com
onclive.com/view/iopofosine-i-131-earns-fda-breakthrough-designation-for-r-r-waldenstr-m-macroglobulinemiaIopofosine I 131 Earns FDA Breakthrough Designation for ...
The FDA has granted breakthrough therapy designation to iopofosine I 131 for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia.
Safety and toxicity of Iopofosine I 131 (CLR ...
The aim of this trial is to evaluate the use of CLR 131 as a modality to provide “internal radiation” combined with external beam radiation ...
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