At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 191 enrolled
Drug / intervention
10 MBq/kg Betalutin +7 moredrug
Likely dose
40 mg lilotomabfrom 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.
A Phase 1/2 Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.
In Brief
A Phase 2 clinical trial evaluating 10 MBq/kg Betalutin, 15 MBq/kg Betalutin, and 6 other interventions for Non-Hodgkin Lymphoma and Follicular Lymphoma. Completed, enrolled 191 participants across 96 sites in 24 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin Lymphoma, Follicular Lymphoma
CountriesAustralia, 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, United States
CollaboratorsICON Clinical Research
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedFeb 2013
Primary CompletionOct 2022
Study CompletionOct 2022
TodayJul 2026
First PostedFeb 21, 2013
Enrollment StartDec 1, 2012
Primary CompletionOct 25, 2022
Study CompletionOct 27, 2022
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 13.4 years ago
Interventions
10 MBq/kg Betalutindrug
15 MBq/kg Betalutindrug
20 MBq/kg Betalutindrug
40 mg lilotomabdrug
100 mg/m2 lilotomabdrug
60 mg/m2 lilotomabdrug
Rituximabdrug
12.5 mBq/kg Betalutindrug