A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)
This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of 177Lu-HH1 (Betalutin)Radioimmunotherapy for Treatment of Relapsed CD37+ Non-Hodgkin Lymphoma|
- Safety/Dose limiting toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Patients are closely monitored during and after injection of Betalutin over a 12 week period. Thereafter, at certain intervals up to 5 years. Safety evaluations are vital signs, physical examination, hematology and serum biochemistry.
Adverse events and abnormal laboratory values will be graded for toxicity according to CTCAE version 4.
- Efficacy [ Time Frame: 3 months - 5 years ] [ Designated as safety issue: No ]CT or PET/CT imaging will be used to quantify changes in lesions on baseline imaging, with responses classified according to revised response criteria for NHL (Cheson, 2007.)
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Betalutin, 10 MBq/kg b.w., in escalated doses.
Dose finding study, starting on 10 MBq/kg b.w. Betalutin (177Lu-Dota-tetulomab), single injection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796171
|Contact: Bjørg Bolstad||+47 22 58 00 firstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0310|
|Contact: Arne Kolstad, MD +47 22934000 ARNEK@ous-hf.no|
|Principal Investigator: Arne Kolstad, MD, PhD|
|St. Olavs hospital||Recruiting|
|Trondheim, Norway, 7006|
|Contact: Unn-Merete Fagerli, Senior consultant Unn.Merete.Fagerli@stolav.no|
|Norrlands University Hospital||Recruiting|
|Contact: Martin Erlanson, MD email@example.com|
|Principal Investigator:||Arne Kolstad, MD, PhD||Oslo University Hospital|