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

NCT01796171 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2024-06-21

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Nordic Nanovector

    lead INDUSTRY

Principal Investigators

  • Chris Freitag · Nordic Nanovector

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2022-10-25
Completion
2022-10-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796171 on ClinicalTrials.gov