CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Betalutindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02658968
NCT02658968Phase 1Completed
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A Phase 1 Dose Finding Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) in Patients With Relapsed/Refractory, Diffuse Large B-cell Lymphoma, Not Eligible for Autologous Stem Cell Transplant

Nordic Nanovector·interventional·Posted Jan 20, 2016·Updated Jan 16, 2024

In Brief

A Phase 1 clinical trial evaluating Betalutin for Relapsed, Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma. Completed, enrolled 18 participants across 10 sites in 5 countries.

Detailed Summary

This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum tolerated dose (MTD) of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who are not eligible for autologous stem cell transplant. The study will also assess safety and tolerability, pharmacokinetics, biodistribution and efficacy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed, Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
CountriesGermany, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 20, 2016
Enrollment StartMar 2, 2017
Primary CompletionJun 4, 2021
Study CompletionJul 10, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.5 years ago

Interventions

Betalutindrug

Dose finding study, starting on 10 MBq/kg b.w. Betalutin® (lutetium (177Lu)-lilotomab satetraxetan), single injection with lilotomab pre-dosing.