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Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL

NCT03806179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-12-22

Study results available
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Summary

This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin in combination with rituximab.

Conditions

Interventions

DRUG

10 MBq/kg Betalutin

10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

DRUG

15 MBq/kg Betalutin

15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Nordic Nanovector

    lead INDUSTRY

Principal Investigators

  • Alexander Fosså, MD.PhD · Oslo University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2022-08-08
Completion
2022-08-08

Countries

  • Czechia
  • Norway

Study Locations

More Related Trials

Entities

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 NCT03806179 on ClinicalTrials.gov