[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
Status:
Recruiting
Trial end date:
2026-04-26
Target enrollment:
Participant gender:
Summary
This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the
safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the
treatment of recurrent or refractory primary or isolated secondary central nervous system
(CNS) lymphoma.
The study will be performed in three cohorts with different dose levels according to the
best-of-5 dose escalation design. A safety review committee (SRC) will evaluate dose-limiting
toxicities and decide about escalation and de-escalation.
Eligible patients will receive one cycle of [90Y]Y-PTT, which will be administered
intravenously. There will be no comparator in this study.
Safety, biodistribution, dosimetry and efficacy will be evaluated during the core study phase
(Visit 1 until Visit 5). Thereafter three follow-up (FU) visits will take place, at
three-months intervals to evaluate the extent of disease.