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A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma
This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.
Details
| Lead sponsor | Nordic Nanovector |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2017-12-19 |
| Completion | 2020-09 |
Conditions
- Non-Hodgkin Lymphoma
Interventions
- Betalutin with lilotomab dose 1
- Betalutin with lilotomab dose 2
Primary outcomes
- Dosimetry — 3 weeks
Estimation of individual tumour/organ uptake and retention of radioactivity.
Countries
Germany