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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2
Universitätsklinikum Würzburg
Würzburg, Germany
Dosimetry
Estimation of individual tumour/organ uptake and retention of radioactivity.
Time frame: 3 weeks
The number of participants with adverse events as assessed by NCTCAE.
Adverse events by treatment group.
Time frame: 12 weeks
Efficacy (Best overall response rate)
Best overall response rate by treatment group as measured by Cheson Criteria.
Time frame: 3 months - 1 year
Lilotomab pharmacokinetics
Estimation using decay correction measurements
Time frame: 3 weeks
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