Efficacy and safety of frontline tislelizumab in patients with de novo Hodgkin lymphoma unsuitable for standard frontline chemotherapy: a phase II, open-label study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503090-11-00

Acronym

FIL_Tisle-HL

Enrollment

Registered

2023-11-16

Start date

2024-05-23

Completion date

Unknown

Last updated

2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin lymphoma

Brief summary

The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).

Detailed description

Duration of response (DoR), Progression Free Survival (PFS), Overall Survival (OS), Disease free survival (DFS), Incidence and severity of adverse events occurred during therapy and up to 90 days after treatment and incidence and severity of serious adverse event occurred from the IC signed to the end of the study (LPLV)

Interventions

DRUGTISLELIZUMAB

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).	—

Secondary

Measure	Time frame
Duration of response (DoR), Progression Free Survival (PFS), Overall Survival (OS), Disease free survival (DFS), Incidence and severity of adverse events occurred during therapy and up to 90 days after treatment and incidence and severity of serious adverse event occurred from the IC signed to the end of the study (LPLV)	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026