Lymrit-37-01 (R/R)

A Phase I/II Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma

Study treatments

• Arm 1: Betalutin 15MBq/kg b.w. with 40 mg lilotomab
• Arm 2: Betalutin 20MBq/kg b.w. with 100mg/m² lilotomab

Inclusion criteria

• Histologically confirmed relapsed non-Hodgkin B-cell follicular lymphoma (grade I-IIIA)
• Age ≥ 18 years
• Received at least 2 prior chemotherapy- or immunotherapy-based regimens (must include rituximab/anti-CD20 agent and alkylating agent)
• Patients must be refractory to the last rituximab/anti-CD20 based treatment
• ECOG score of 0-2
• Bone marrow tumour infiltration < 25%
• Measurable disease by CT: longest diameter > 1,5 cm for nodal lesion
• Negative HAMA test at screening

Exclusion criteria

• Prior hematopoietic allogenic stem cell transplantation
• Prior autologous stem cell transplantation
• Evidence of histological transformation from follicular lymphoma to diffuse large B-cel lymphoma

Participating sites

• University Hospital Gasthuisberg Leuven