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OncoMatch/Clinical Trials/NCT05977673

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

Is NCT05977673 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab for hodgkin lymphoma.

Phase 2RecruitingFondazione Italiana Linfomi - ETSNCT05977673Data as of May 2026

Treatment: TislelizumabThis 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.

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Extracted eligibility criteria

Cancer type

Hodgkin Lymphoma

Disease stage

Excluded: Stage IA WITHOUT A LARGE TUMOR BURDEN

all stages except IA without a large tumor burden

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any previous treatment for HL

Any previous treatment (including radiation therapy) for HL

Lab requirements

Blood counts

ANC > 1 x 10^9/L (without growth factor support within 7 days of ANC measurement), unless due to bone marrow involvement by lymphoma; Platelet > 50 x 10^9/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)

Kidney function

Creatinine clearance ≥ 30 ml/min (Cockcroft-Gault or measured)

Liver function

AST/ALT ≤ 3.0 × ULN; Serum total bilirubin < 1.5 × ULN (or < 3 x ULN in case of documented Gilbert's syndrome)

Adequate organ and marrow function as defined below: - ANC > 1x10^9/L (without growth factor support within 7 days of ANC measurement), unless due to bone marrow involvement by lymphoma - Platelet > 50 x 10^9/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 (Cockcroft-Gault or measured) - AST/ALT ≤ 3.0 × ULN - Serum total bilirubin < 1.5 × ULN (or < 3 x ULN in case of documented Gilbert's syndrome)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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