Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT05977673
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    Tislelizumab 200mg IV day1

Study Details

This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy.

Key Dates

First listed
Aug 4, 2023
Start date
May 23, 2024
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab
    Tislelizumab single dose every 3 weeks up to 35 total administration

Primary Outcome Measure

Overall Response Rate (CR + PR) [ Time Frame: From treatment start up to about 24 months ]

Central Contacts

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