News_Sperimentazioni_2019_10.pdf (230,9 KB)
Phase I / II study of lutetium antibody-radionuclide conjugate
(177Lu) -lilotomab satetraxetan (Betalutin®) for the treatment of
relapsing non-Hodgkin’s lymphoma
Principal Investigator: Dr. Marco Ladetto, Director, S.C. Hematology
Study typology: Phase II open-label clinical pharmacological study
randomized, international, multicenter, profit
Promoter: Nordic Nanovector ASA, Oslo, Norway
Acronym: LYMRIT-37-01
Objective: Phase II of the study plans to explore tumor response rates
in patients treated with Betalutin. In particular, the study aims to evaluate
the efficacy of the “40/15” regimen (40 mg lilotomab / 15 MBq / kg Betalutin)
compared to the “100/20” regimen (100 mg / m2 lilotomab / 20 MBq / kg Betalutin),
based on the evaluation, by an independent audit committee (IRC),
of tumor response rates in adult patients with follicular lymphoma
relapsed refractory to rituximab / anti-CD20.
Phase II of the study will be held at the company. Phase I was conducted in
other experimental centers.
Study drugs: Betalutin or Lutetium (177Lu) -lilotomab satetraxetan, Rituximab,
Lilotomab
Study population: The study foresees the participation of 7 Italian centers
and an enrollment of 20 adult patients with follicular lymphoma (LF)
relapsed who received ≥ 2 previous chemotherapy regimens or
immunotherapy, and which are refractory to the last anti-CD20-based regimen. There
Previous therapy must include an anti-CD20 therapy and an agent
alkylating. Anti-CD20 refractory disease is defined as lack
of a complete remission (CR) or partial remission (PR), or PD within 6 months
since the last dose. Previous exposure to idelalisib is also permitted
other PI3K inhibitors (Phosphatidylinositol-3-kinase).
Overall, the study includes 130 patients enrolled,
randomized 1: 1. Once treated the first 50 patients (about 25 for each
arm), an interim analysis will be performed to assess futility.
The company is expected to enroll 1-2 patients.
Study Planning: The study includes a screening period, of
treatment and follow-up. All patients will be followed for a maximum total of
five years or until further anticancer therapy is administered.
Expected start of the trial in Italy: 31 May 2018
Expected end of the enrollment period: 30 March 2019
Expected end of the trial: December 14, 2024