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.


This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study.

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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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society