Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A pivotal Phase III randomized, controlled trial of iopofosine I 131 versus a comparator arm for treatment of relapsed/refractory Waldenstrom's-macroglobulinaemia.

Next Previous
Trial Profile

A pivotal Phase III randomized, controlled trial of iopofosine I 131 versus a comparator arm for treatment of relapsed/refractory Waldenstrom's-macroglobulinaemia.

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 25 Mar 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Iopofosine I 131 (Primary)
  • Indications Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 13 Mar 2025 According to a Cellectar Biosciences media release, there will be Two-stage approval process includes conditional accelerated approval based on a major response rate (MRR) endpoint with full approval based upon achieving a progression-free survival endpoint. The Company expects to complete full patient enrollment within 24 months of the first patient admitted to the study. Total study cost is expected to be between $40M-$45M, with approximately $30M to full enrollment.
  • 13 Mar 2025 According to a Cellectar Biosciences media release, the company completed a productive meeting with the US FDA that established a clear regulatory pathway and confirmatory study design for the accelerated approval of iopofosine I 131 as a treatment for Waldenstrom macroglobulinemia (WM).
  • 27 Nov 2016 New trial record

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top