OncRef

Clinical Trial: NCT01796171

A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Nordic Nanovector
Information Provided By:Nordic Nanovector
Last Update Posted:2024-06-21

Study Overview

Brief Summary

This study is a Phase 1/2 open-label three part study in patients with relapsed indolent Non-Hodgkin's lymohoma (NHL) (Parts A and C) or relapsed/refractory follicular lymphoma (FL) (Part B).

Official Title

A Phase 1/2 Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

Conditions

Non-Hodgkin Lymphoma, Follicular Lymphoma

Intervention / Treatment

  • Drug: 10 MBq/kg Betalutin
  • Drug: 15 MBq/kg Betalutin
  • Drug: 20 MBq/kg Betalutin
  • Drug: 40 mg lilotomab
  • Drug: 100 mg/m2 lilotomab
  • Drug: 60 mg/m2 lilotomab
  • Drug: Rituximab
  • Drug: 12.5 mBq/kg Betalutin

Other Study ID Numbers

  • EudraCT: 2011-000033-36

Start Date (Actual)

2012-12

Primary Completion Date (Actual)

2022-10-25

Study Completion Date (Actual)

2022-10-27

Enrollment (Actual)

191

Study Type

Interventional

Phase

Phase 1, Phase 2