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An Open-Label, Multicenter, Randomized, Phase 3 Trial of Iopofosine I 131 Versus Rituximab-Cyclophosphamide-Dexamethasone (R-CD) in Waldenstrom Macroglobulinemia Patients Previously Treated With a Bruton Tyrosine Kinase Inhibitor

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Trial Profile

An Open-Label, Multicenter, Randomized, Phase 3 Trial of Iopofosine I 131 Versus Rituximab-Cyclophosphamide-Dexamethasone (R-CD) in Waldenstrom Macroglobulinemia Patients Previously Treated With a Bruton Tyrosine Kinase Inhibitor

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Aug 2026

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At a glance

  • Drugs Iopofosine I 131 (Primary) ; Cyclophosphamide; Dexamethasone; Rituximab
  • Indications Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Cellectar Biosciences

Most Recent Events

  • 13 Aug 2026 According to a Cellectar Biosciences media release, clinical trial sites are expected to begin opening in the coming months, with the first patient anticipated to be dosed in early 2027.
  • 01 Jun 2026 Results presented in the Cellectar Biosciences Media Release.
  • 01 Jun 2026 According to a Cellectar Biosciences media release, Based on these findings, we plan to pursue accelerated approval in the U.S. and initiate a confirmatory Phase 3 study in the fourth quarter of 2026. We remain committed to bringing iopofosine to the thousands of patients who may benefit from this therapy.

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