Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

  • End date
    Oct 31, 2022
  • participants needed
  • sponsor
Updated on 28 June 2021
Eric Hedrick, MD
Primary Contact
Centre Hospitalier R gional Universitaire de Lille (CHRU) - H pital Claude Huriez (0.0 mi away) Contact
+41 other location
measurable disease
chemotherapy regimen
refractory classical hodgkin lymphoma


The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

Condition Classical Hodgkin Lymphoma
Treatment tislelizumab
Clinical Study IdentifierNCT04318080
Last Modified on28 June 2021


Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of relapsed or refractory cHL
Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria
Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell
transplant (HSCT) and brentuximab vedotin
Has failed to achieve a response or progressed after autologous HSCT and failed to achieve a response or progressed after brentuximab vedotin
Is not a candidate for additional autologous or allogeneic HSCT
Cohort 2: Relapsed or refractory to salvage chemotherapy, including
brentuximab vedotin, and has not received prior autologous or allogeneic HSCT
Is not a candidate for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy
Has received at least 2 prior systemic chemotherapy regimens for cHL and failed to achieve a response or progressed after brentuximab vedotin
Measurable disease defined as 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is > 1.5 cm in the longest diameter, or 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter
Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
Prior allogeneic hematopoietic stem cell transplantation
Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways
Active autoimmune disease or history of autoimmune disease that may relapse
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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