Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)
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|ClinicalTrials.gov Identifier: NCT02657447|
Recruitment Status : Not yet recruiting
First Posted : January 15, 2016
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin Lymphoma||Drug: Betalutin with lilotomab dose 1 Drug: Betalutin with lilotomab dose 2||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||July 2019|
Experimental: Arm 1: Betalutin with lilotomab dose 1
Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing
Drug: Betalutin with lilotomab dose 1
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1
Experimental: Arm 2: Betalutin with lilotomab dose 2
Betalutin 15MBq/kg b.w. with lilotomab pre-dosing
Drug: Betalutin with lilotomab dose 2
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2
- Dosimetry [ Time Frame: 3 weeks ]Estimation of individual tumour/organ uptake and retention of radioactivity.
- The number of participants with adverse events as assessed by NCTCAE. [ Time Frame: 12 weeks ]Adverse events by treatment group.
- Efficacy (Best overall response rate) [ Time Frame: 3 months - 1 year ]Best overall response rate by treatment group as measured by Cheson Criteria.
- Lilotomab pharmacokinetics [ Time Frame: 3 weeks ]Estimation using decay correction measurements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657447
|Contact: Laurie Baylor Curtis||+44 firstname.lastname@example.org|
|Universitätsklinikum Würzburg||Not yet recruiting|
|Principal Investigator:||Andreas Buck, Prof. MD||Wuerzburg University Hospital|