RecruitingPhase 2NCT05977673

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

Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy: a Phase II, Open-label Study

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

28 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

Hodgkin Lymphoma

Summary

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tislelizumab — an immunotherapy drug — as a first-line treatment for older adults with newly diagnosed classical Hodgkin lymphoma (a cancer of the lymph system) who are not healthy enough to tolerate standard intensive chemotherapy. **You may be eligible if...** - You are 65 or older - You have been newly diagnosed with classical Hodgkin lymphoma confirmed by biopsy - You have not received any prior treatment for this lymphoma - You are not suitable for standard front-line chemotherapy, typically because of other health conditions - Your cancer is measurable on imaging (PET/CT scans) **You may NOT be eligible if...** - You have previously received treatment for Hodgkin lymphoma - You have active autoimmune disease or a major infection - Your overall health would not tolerate immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

Tislelizumab 200mg IV day1

Locations(10)

A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia

Alessandria, IT, Italy

Divisione di Oncologia e dei Tumori immuto-correlati, Centro Di Riferimento Oncologico Di Aviano

Aviano, Italy

Istituto di Ematologia L. e A. Seràgnoli, AOU Policlinico S. Orsola-Malpighi

Bologna, Italy

SC Ematologia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, Italy

Ematologia, Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, Italy

Unità di Ematologia e TMO - Unità Linfomi, Ospedale San Raffaele

Milan, Italy

Oncologia, IRCCS Istituto Nazionale Tumori Fondazione Pascale

Naples, Italy

Oncoematologia, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

Palermo, Italy

Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Azienda Ospealiero Universitaria Policlinico Umberto I

Roma, Italy

U.O di Oncologia Medica ed Ematologia, Humanitas Research Hospital

Rozzano, Italy

View Full Details on ClinicalTrials.gov

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NCT05977673

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