A Phase I/II Study of (177Lu)-Lilotomab (Betalutin) Radioimmunotherapy for Treatment of Relapsed Non-Hodgkin Lymphoma.

Trial Profile

A Phase I/II Study of (177Lu)-Lilotomab (Betalutin) Radioimmunotherapy for Treatment of Relapsed Non-Hodgkin Lymphoma.

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Lutetium-(177lu) lilotomab satetraxetan (Primary) ; Rituximab
  • Indications Follicular lymphoma; Mantle-cell lymphoma; Marginal-zone-B-cell-lymphoma; Non-Hodgkin's lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms LYMRIT37-01
  • Sponsors Nordic Nanovector
  • Most Recent Events

    • 08 Dec 2017 According to a Nordic Nanovector media release, company will host a conference call and audio cast on 11 December at 08:00 CET to present the updated results from this trial.
    • 08 Nov 2017 According to a Nordic Nanovector media release, the application for protocol amendment is based on a plan for PARADIGME to be a global Phase 2b clinical trial to compare the two dosing regimens from LYMRIT 37-01 in approximately 130 patients, 15 MBq/kg Betalutin after 40 mg lilotomab pre-dosing and 20 MBq/kg Betalutin after 100 mg/m2 lilotomab pre-dosing.
    • 08 Nov 2017 According to a Nordic Nanovector media release, an application for a Protocol Amendment to the LYMRIT 37-01 study, for the planned pivotal Phase 2b clinical trial has been published by MHRA (Medicines and Healthcare products Regulatory Agency). The application for the Protocol Amendment is under-going review by the MHRA. The board of directors of Nordic Nanovector will decide on the final structure and initiation of the study upon response from regulatory authorities.
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