TerminatedPhase 3

Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma

Stopped: Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern.

China3 participantsStarted 2020-12-14

Plain-language summary

The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or
✓. Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate.

Exclusion criteria

✕. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma.
✕. Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug.
✕. Prior therapies targeting PD-1 or PD-L1.
✕. Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
✕. Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
✕. Serious acute or chronic infection requiring systemic therapy.
✕. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

What they're measuring

Progression-free Survival (PFS) by Investigator

Timeframe: Up to 45 months

Trial details

NCT IDNCT04486391

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-13

View on ClinicalTrials.gov More Classical Hodgkin Lymphoma trials