NCT01796171

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

A Phase 1/2 Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Nordic Nanovector · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Part A of the study was a Phase 1/2a study to assess the safety and preliminary efficacy of different treatment regimens of Betalutin with expansion at the candidate recommended Phase 2 doses. Part B was a dedicated Phase 2b randomized substudy to further assess the efficacy and safety of the candidate recommended Phase II doses. Part C was a Phase 2a fixed dose expansion cohort planned to obtain supplementary pharmacokinetic data.

Conditions

• Non-Hodgkin Lymphoma
• Follicular Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-12-01
• Primary completion: 2022-10-25
• Completion: 2022-10-27
• First posted: 2013-02-21
• Last updated: 2024-06-21
• Results posted: 2024-01-10

Locations

96 sites across 24 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

Regulatory

• FDA-regulated drug study