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.
Histologically confirmed diagnosis of de novo classical Hodgkin Lymphoma (cHL). Note: Availability of either block or unstained slides plus stained slides used by the local pathologist to make diagnosis, and of all pathology reports is mandatory for the study to perform central pathology review for confirmation of cHL diagnosis and for biological biomarkers assessments. Central pathology confirmation is not required to start treatment;
Patients >= 65 years ineligible for frontline standard chemotherapy (mainly due to medical comorbidities);
Treatment naïve;
Measurable disease defined as presence of both fluorodeoxyglucose-avid nodal involvement and at least one nodal target lesion measurable in two diameters (and at least 1.5 cm in its major diameter); • Indication for systemic treatment, i.e., all stages except IA without a large tumor burden, as radiotherapy is regarded curative in those patients;
Nodular lymphocyte predominant HL;
Any previous treatment (including radiation therapy) for HL;
Any active autoimmune disease requiring systemic treatment (including disease-modifying agents, corticosteroids, immunosuppressants) in the past 2 years; Note: Patients with the following diseases are not excluded and may proceed to further screening: Type I diabetes under control; Hypothyroidism (provided it is managed with hormone replacement therapy only); Controlled celiac disease;
Has known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases or evidence of dyspnea at rest or pulse oximetry of < 92% while breathing room air;
Single group
Tislelizumab
DrugTislelizumab 200mg IV day1
Overall Response Rate (CR + PR)
The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).
Duration of response (DoR)
Time from first documented complete response according to Lugano and LYRIC criteria to disease relapse.
Progression-free survival (PFS)
Time from registration to the earliest date of documentation of disease progression, relapse or death from any cause.
Overall survival (OS)
Time from registration to death from any cause.
Disease free survival (DFS)
Time from first documented complete response according to Lugano and LYRIC criteria to disease relapse or death as a result of lymphoma or acute toxicity of treatment.
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