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

NCT05977673 | Recruiting Phase 2

• 1 other identifier: FIL_Tisle-HL
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Hodgkin Lymphoma

Keywords

Lymphoma; Hodgkin; Tislelizumab; PD1; Checkpoint; Inhibitor; De novo; Unsuitable; Chemotherapy; Immune

Outcome Measures

Primary Outcomes (1)

• 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).

  From treatment start up to about 24 months

Secondary Outcomes (5)

• Duration of response (DoR)

  Between +33 days after treatment start up to 66 months

• Progression-free survival (PFS)

  From registration up to 66 months

• Overall survival (OS)

  From registration up to 66 months

• Disease free survival (DFS)

  Between +33 days after treatment start up to 66 months

• Incidence and severity of adverse events occurred during therapy and up to 90 days after treatment and incidence and severity of serious adverse events occurred from the IC signed to the end of the study (LPLV)

  From treatment start up to 66 months

Study Arms (1)

Tislelizumab

EXPERIMENTAL

Tislelizumab single dose every 3 weeks up to 35 total administration

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Tislelizumab 200mg IV day1

Tislelizumab

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2;
• Adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) \> 109/L (without growth factor support within 7 days of ANC measurement), unless due to bone marrow involvement by lymphoma
• Platelet \> 50 x 109/L (without growth factor support or transfusion within 7 days of platelets measurement) , unless due to bone marrow involvement by lymphoma
• Hemoglobin \> 8 g/dL (prior transfusion is acceptable)
• Creatinine clearance ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24-hour urine collection)
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤ 3.0 × upper limit of normal (ULN)
• Serum total bilirubin \< 1.5 × ULN (or \< 3 x ULN in case of documented Gilbert's syndrome)
• Life expectancy ≥ 6 months;
• Men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 4 months after last tislelizumab dose. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control method, e.g. vasectomy, use of condoms or complete sexual abstinence, when this is in line with the preferred and usual lifestyle of the subject.The use of condoms by male patients is required unless the female partner is permanently sterile. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner) and withdrawal are not acceptable methods of contraception.
• Subject voluntarily signs and dates an informed consent form approved by an National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures, indicating that they understand the purpose of and procedures required for the study and are willing to participate in it;

You may not qualify if:

• 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;
• A history of previous exposure to anti-PD1, anti-PDL1 or anti-PDL2 or anti-CTLA-4 agents for any disease other than HL;
• Use of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days from registration; Note: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
• Known infection with HIV, human T-cell lymphotropic virus-1, -2; • Serologic status reflecting active hepatitis B defined as presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) (mandatory testing). Patients with occult or prior HBV infection (respectively defined as patient with HBsAg-/HBcAb+ and patients HBsAg+ with HBV DNA undetectable) are eligible, provided that they are willing to undergo prophylactic antiviral medication according to local standard of care. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination are eligible;
• Presence of hepatitis C virus (HCV) antibody (mandatory HCV antibody serology testing). Patients with presence of HCV antibody are eligible only if PCR is negative for HCV RNA;
• Hypersensitivity to tislelizumab or any of its excipients;
• Active central nervous system (CNS) involvement or leptomeningeal metastases involvement;
• Evidence of other clinically significant uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens;
• Major surgery within 4 weeks of the first dose of study drug;
• Vaccination with a live vaccine within 4 weeks prior to the first dose of study drug;
• Clinically significant cardiovascular disease including the following:

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (10)

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

Alessandria, IT, Italy

RECRUITING

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

Aviano, Italy

RECRUITING

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

Bologna, Italy

RECRUITING

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

Brescia, Italy

RECRUITING

Ematologia, Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, Italy

RECRUITING

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

Milan, Italy

RECRUITING

Oncologia, IRCCS Istituto Nazionale Tumori Fondazione Pascale

Naples, Italy

RECRUITING

Oncoematologia, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

Palermo, Italy

NOT YET RECRUITING

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

Roma, Italy

RECRUITING

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

Rozzano, Italy

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uffici Studi FIL

CONTACT

+390131033153; startup@filinf.it

Uffici Studi FIL

CONTACT

+390599769913; gestionestudi@filinf.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: May 23, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

IT (10)