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Evaluation of Iopofosine I 131 vs. R-CD in WM Patients

StatusNot Yet Recruiting
PhasePhase 3
Started2026-12
View on ClinicalTrials.gov ↗
The goal of this clinical trial is to evaluate whether iopofosine I 131 is more effective than the combination Rituximab-Cyclophosphamide-Dexamethasone (R-CD). The main question the study aims to answer is: • Does iopofosine I 131 work better than R-CD when looking at the length of time during and after the treatment that a patient lives with WM but it does not get worse. Participants will: * Be randomly assigned to received either iopofosine I 131 or R-CD. * If assigned to iopofosine I 131, have it administered via infusion 2 times each cycle for a total of 2 cycles (each cycle is about 3 months long). * If assigned to R-CD, it will be administered for up to six cycles, and each cycle is 3-weeks long * Visit the clinic once every 3 weeks for checkups and testing. * Report any side effects or new medications.
Trial Details
NCT Number NCT07766421
Lead Sponsor Cellectar Biosciences, Inc.
Conditions Waldenstrom Macroglobulinaemia, Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinaemia Refractory, Waldenstrom Macroglobulinemia With Nodal Disease, Waldenstrom's Macroglobulinemia Recurrent
Enrollment 219 participants
Start Date 2026-12
Primary Completion 2032-01 (estimated)
Study Completion 2035-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-14