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An Open-Label, Multicenter, Phase 2 Study of Iopofosine I 131 (CLR 131) in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients With Waldenstrom Macroglobulinemia (CLOVER-WaM)

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An Open-Label, Multicenter, Phase 2 Study of Iopofosine I 131 (CLR 131) in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients With Waldenstrom Macroglobulinemia (CLOVER-WaM)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Dec 2024

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At a glance

  • Drugs Iopofosine I 131 (Primary) ; Dexamethasone
  • Indications B-cell lymphoma; Chronic lymphocytic leukaemia; CNS cancer; Diffuse large B cell lymphoma; Lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Multiple myeloma; Non-Hodgkin's lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CLOVER I; CLOVER-WaM
  • Sponsors Cellectar Biosciences

    • Most Recent Events

    • 10 Dec 2024 According to a Cellectar Biosciences media release, the CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end of Phase 2 meeting and from a meeting in early 2024, during which the Company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom's macroglobulinemia (WM).
    • 10 Dec 2024 According to a Cellectar Biosciences media release, Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS).
    • 18 Nov 2024 According to a Cellectar Biosciences media release, a conference call and webcast has been scheduled on November 18, 2024, at 8:30 AM Eastern Time to discuss these results and answer questions.

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