CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
10 MBq/kg Betalutin +1 moredrug
Likely dose
10 MBq/kg Betalutin 40mgfrom 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/NCT03806179
NCT03806179Phase 1Completed
CompareCT.gov

A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)

Nordic Nanovector·interventional·Posted Jan 16, 2019·Updated Dec 22, 2023

In Brief

A Phase 1 clinical trial evaluating 10 MBq/kg Betalutin and 15 MBq/kg Betalutin for Non Hodgkin Lymphoma and 2 related conditions. Completed, enrolled 7 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Hodgkin Lymphoma, Follicular Lymphoma, Relapsed Follicular Lymphoma
CountriesCzechia, Norway
CollaboratorsICON Clinical Research

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 16, 2019
Enrollment StartOct 4, 2018
Primary CompletionAug 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.5 years ago

Interventions

10 MBq/kg Betalutindrug

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

15 MBq/kg Betalutindrug

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