Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

  • End date
    Mar 30, 2024
  • participants needed
  • sponsor
Updated on 22 December 2021
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 on22 December 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)
Has failed to achieve a response or progressed after autologous HSCT
Is not a candidate for additional autologous or allogeneic HSCT
Cohort 2: Relapsed or refractory to salvage chemotherapy, and has not received prior
autologous or allogeneic HSCT
Is not a candidate for autologous or allogeneic HSCT
Has received at least 1 prior systemic regimen for cHL
Measurable disease defined as ≥ 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal
Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1
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

Exclusion Criteria

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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