Non Hodgkin Lymphoma Clinical Trial
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Summary
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.
Eligibility Criteria
Key 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 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
Key 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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There are 35 Locations for this study
Detroit Michigan, 48201, United States
Basking Ridge New Jersey, 07920, United States
Bergen New Jersey, 07645, United States
Monmouth Junction New Jersey, 07748, United States
Commack New York, 11725, United States
Nassau New York, 11553, United States
New York New York, 10065, United States
Westchester New York, 10604, United States
Knoxville Tennessee, 37920, United States
Salt Lake City Utah, 84112, United States
Albury New South Wales, 2640, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Bruxelles , 1000, Belgium
Liège , 4000, Belgium
Yvoir , 5530, Belgium
Villejuif Val De Marne, 94805, France
Caen , 14033, France
Créteil , 94010, France
Dijon , 21000, France
La Roche-sur-Yon , 85925, France
Le Chesnay , 78157, France
Lille , 59307, France
Limoges , 87042, France
Montpellier , 34090, France
Nantes , 44093, France
Paris , 75475, France
Pessac , 33604, France
Pierre-Bénite , 69495, France
Rouen , 76038, France
Strasbourg , 67098, France
Toulouse , 31059, France
Vandœuvre-lès-Nancy , 54511, France
Rio Piedras , 00935, Puerto Rico
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