A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma

Official Title

A Phase I/II Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

Summary:

This study is a phase I/II, open-label study in patients with relapsed indolent non-Hodgkin lymphoma. Part A of the study included a phase I dose escalation to define the maximum tolerated / recommended dose for expansion of (177Lu)-lilotomab (Betalutin), and a phase IIa part to evaluate safety and preliminary efficacy. Part B of the study will assess the efficacy and safety of two different Betalutin/lilotomab dosing regimens in adult patients with relapsed rituximab / anti-CD20-refractory follicular lymphoma who have received 2 or more prior therapies.

Trial Description

Primary Outcome:

  • Part A, Phase I
  • Part A, Phase IIa
  • Part B, Phase IIb

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society