Clinical Trial · NCT02657447

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

Overview

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.

Sponsor

Nordic Nanovector

Phase

Phase 1

Contacts

Andreas Buck, Prof. MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02657447

Drug / Compound

lilotomab satetraxetan

Isotope(s):

Target(s):

CD37

Ligand Class: Antibodies

Chelator: DOTA

Eligibility

Inclusion

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.
Exhausted and/or ineligible for all standard treatment options.
Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
1. Histologically confirmed (by WHO classification) relapsed indolent non-Hodgkin B-cell lymphoma of following subtypes: Follicular lymphoma (follicular grade I-IIIA), Marginal zone lymphoma (exclusion of MZL if large lymphocytes \> 50%), Small lymphocytic lymphoma, Lymphoplasmacytoid and classical mantle cell lymphoma (no blastoid MCL).
Requiring initiation of treatment for the NHL.

Exclusion

Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l
1. Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.
Laboratory values during screening :
Platelet count ≤ 150 x 109 /l
Total bilirubin ≥ 30 mmol/l