Beschreibung

Prospective, multicenter, single-arm, open-label, phase II study with a safety run-in (irrespective of CAR-T status) and efficacy run-in (CAR-T naive patients only) phases

Studienstatus

geplant, Rekrutierung startet in Kürze

Allgemeine Infos zum Antrag

Best overall response rate (complete plus partial remission rate) (BORR) in the study population achieved up to 12-months of treatment with loncastuximab tesirine and epcoritamab

Secondary objectives for efficacy:
- Progression-free survival (PFS)
- Overall survival (OS)
- Complete remission (CR) rate
- Partial remission (PR) rate
- Time to complete response
- Time to best response
- Duration of response (DOR)
- BORR after 18- and 24-months of treatment
- Progression rate
- Relapse rate
- Outcomes according to biological characteristics of the
lymphoma
Secondary objectives for safety and tolerability:
- Rate of treatment-related deaths
- Safety and tolerability, and protocol adherence of
epcoritamab and loncastuximab tesirine

Patients older than 18 years with DLBCL, HGBL or FL grade 3B who failed first-line immunochemotherapy administered at
least one time.
Patients older than 18 years with DLBCL, HGBL or FL grade 3B who failed second-line therapy with CAR-T cells.

120 patients with histologically confirmed relapsed/refractory DLBCL, HGBL or FL grade 3B, including 20 patients treated in the safety run-in phase (irrespective of CAR-T status) and
20 patients treated in the efficacy run-in phase (CAR-T naive only).
The number of patients with previous CAR-T treatment will be capped at n=60

Best overall response rate (BORR) of relapsed/refractory DLBCL, HGBL and FL grade 3B patients defined as the proportion of patients who achieve a complete or partial remission as best response up to 12-months of treatment
according to the 2014 Lugano criteria after failing first-line immunochemotherapy administered at least one time or second-line therapy with CAR-T cells.

Secondary endpoints for efficacy:
- PFS
- OS
- CR rate
CLEAR, Study Protocol, Version 1.3
07.07.2025
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- PR rate
- Time to complete response
- Time to best response
- DOR
- BORR after 18- and 24-months of treatment
- Progression rate
- Relapse rate
- Outcomes according to biological characteristics of
DLBCL
Secondary endpoints for safety and tolerability:
- Adverse events (AEs)
- Serious AEs (SAEs)
- Rate of treatment related deaths
Secondary endpoints for protocol adherence:
- Number of treatment cycles received
- Duration of treatment cycles
- Cumulative doses of loncastuximab tesirine and
epcoritamab

Spezifische Infos zum Antrag

First patient in: Q3/2025
Last patient in: Q1/2027
Planned overall duration of the study: 4.5 years

A maximum of 35 institutions will be included with sites active in the German Lymphoma Alliance (GLA) (31 institutions) and the Italian Study Group Fondazione Italiana Linfomi (FIL) (4 institutions)

AbbVie
Sobi

Ja

• CLEAR_Synopse