New hope for hodgkin lymphoma patients unable to tolerate chemo
NCT ID NCT05977673
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study tests a drug called tislelizumab in people with newly diagnosed Hodgkin lymphoma who are not able to receive standard chemotherapy. The goal is to see if the drug can shrink or control the cancer. About 28 participants will take part in this phase 2 trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * Subject must be able to adhere to the study visit schedule and other protocol requirements, and to return to enrolling institution for follow-up (during the active monitoring phase of the study). Exclusion Criteria: * 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: * Myocardial infarction within 6 months before screening; * Unstable angina within 3 months before screening; * New York Heart Association Classification III or IV congestive heart failure; * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes); * QTcF \> 480 msecs based on Fridericia's formula; * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \> 170 mm Hg and diastolic blood pressure \> 105 mm Hg at screening; * Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent; * Any history of other active malignancies within 3 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent; * History of severe hypersensitivity reactions to other monoclonal antibodies; * Concurrent participation in another therapeutic clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
RECRUITINGAlessandria, IT, Italy
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Divisione di Oncologia e dei Tumori immuto-correlati, Centro Di Riferimento Oncologico Di Aviano
RECRUITINGAviano, Italy
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Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
NOT_YET_RECRUITINGReggio Emilia, Italy
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Ematologia, Fondazione IRCCS Istituto Nazionale Dei Tumori
RECRUITINGMilan, Italy
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Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Azienda Ospealiero Universitaria Policlinico Umberto I
RECRUITINGRoma, Italy
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Istituto di Ematologia L. e A. Seràgnoli, AOU Policlinico S. Orsola-Malpighi
RECRUITINGBologna, Italy
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Oncoematologia, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
RECRUITINGPalermo, Italy
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Oncologia, IRCCS Istituto Nazionale Tumori Fondazione Pascale
RECRUITINGNaples, Italy
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SC Ematologia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
RECRUITINGBrescia, Italy
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SCDU Ematologia - AOU Maggiore della Caritа di Novara
NOT_YET_RECRUITINGNovara, Italy
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U.O di Oncologia Medica ed Ematologia, Humanitas Research Hospital
RECRUITINGRozzano, Italy
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Unità di Ematologia e TMO - Unità Linfomi, Ospedale San Raffaele
RECRUITINGMilan, Italy
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