Actively Recruiting
Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy
Led by Fondazione Italiana Linfomi - ETS · Updated on 2025-12-08
28
Participants Needed
10
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of de novo classical Hodgkin Lymphoma (cHL) with available tissue samples for review
- Patients aged 65 years or older who are ineligible for standard frontline chemotherapy mainly due to medical comorbidities
- Treatment-na�efve patients
- Measurable disease with fluorodeoxyglucose-avid nodal involvement and at least one nodal lesion measurable in two diameters (minimum 1.5 cm in major diameter)
- Indication for systemic treatment (all stages except IA without large tumor burden)
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate organ and marrow function as defined by specified blood counts and liver/kidney function tests
- Life expectancy of at least 6 months
- Men must agree to use effective contraception during the study and for 4 months after last dose
- Ability to voluntarily sign informed consent
- Ability to adhere to study visit schedule and return for follow-up during active monitoring phase
You will not qualify if you...
- Diagnosis of nodular lymphocyte predominant Hodgkin Lymphoma
- Any previous treatment for Hodgkin Lymphoma including radiation therapy
- Active autoimmune disease requiring systemic treatment in the past 2 years (except controlled type I diabetes, hypothyroidism managed with hormone replacement, or controlled celiac disease)
- History of interstitial lung disease, pneumonitis, pulmonary fibrosis, acute lung diseases, dyspnea at rest, or low oxygen saturation (<92%) on room air
- Previous exposure to anti-PD1, anti-PDL1, anti-PDL2, or anti-CTLA-4 agents for any disease other than Hodgkin Lymphoma
- Use of systemic corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive medications within 14 days before registration (inhaled or topical steroids permitted if no active autoimmune disease)
- Known infection with HIV or human T-cell lymphotropic virus-1 or -2
- Active hepatitis B or C infection (with specific testing requirements and conditions for eligibility)
- Hypersensitivity to tislelizumab or its components
- Active central nervous system involvement or leptomeningeal metastases
- Clinically significant uncontrolled or active systemic infections including SARS-CoV-2
- Severe concurrent diseases or conditions that interfere with safety assessment
- Major surgery within 4 weeks before first study drug dose
- Vaccination with live vaccine within 4 weeks before first study drug dose
- Significant cardiovascular disease including recent myocardial infarction, unstable angina, severe heart failure, serious arrhythmias, high QTcF interval, certain heart blocks, or uncontrolled hypertension
- History of severe neurologic, psychiatric, endocrine, metabolic, immunologic, or liver diseases affecting consent or participation
- Other active malignancies within 3 years prior to study entry, except certain treated skin or cervical cancers
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Alessandria, IT, Italy
Actively Recruiting
2
Divisione di Oncologia e dei Tumori immuto-correlati, Centro Di Riferimento Oncologico Di Aviano
Aviano, Italy
Actively Recruiting
3
Istituto di Ematologia L. e A. Seràgnoli, AOU Policlinico S. Orsola-Malpighi
Bologna, Italy
Actively Recruiting
4
SC Ematologia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy
Actively Recruiting
5
Ematologia, Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Italy
Actively Recruiting
6
Unità di Ematologia e TMO - Unità Linfomi, Ospedale San Raffaele
Milan, Italy
Actively Recruiting
7
Oncologia, IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, Italy
Actively Recruiting
8
Oncoematologia, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Not Yet Recruiting
9
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, Italy
Actively Recruiting
10
U.O di Oncologia Medica ed Ematologia, Humanitas Research Hospital
Rozzano, Italy
Actively Recruiting
Research Team
U
Uffici Studi FIL
CONTACT
U
Uffici Studi FIL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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