WithdrawnPhase 1

Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)

Stopped: Study is no longer relevant

Germany0Started 2017-12-19

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Requiring initiation of treatment for the NHL.
✕. Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
✕. Exhausted and/or ineligible for all standard treatment options.
✕. Not a candidate for an autologous or allogeneic stem cell transplantation. Patients in progression after successful stem cell collection before before high-dose therapy and autologous stem cell transplantation may be considered for enrolment.
✕. Age ≥ 18 years..
✕. A pre-study ECOG performance status of 0-2. In selected patients an ECOG score of 3 can be acceptable if it is clearly lymphoma-associated at the discretion of the investigator.
✕. Life expectancy should be ≥ 3 months.
✕. 9\. \< 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment (biopsy taken from a site not previously irradiated).

What they're measuring

Dosimetry

Timeframe: 3 weeks

Trial details

NCT IDNCT02657447

SponsorNordic Nanovector

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09

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