Status:
COMPLETED
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Lead Sponsor:
BeiGene
Collaborating Sponsors:
Lymphoma Study Association
Conditions:
Classical Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior tre...
Eligibility Criteria
Inclusion
- Key
- Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
- Participants had either:
- Relapsed cHL, defined as disease progression after a partial response (PR) or complete response (CR) to their most recent therapy; or
- Refractory cHL, defined as failure to achieve PR or CR to their most recent therapy.
- Participants were assigned to one of two cohorts based on the following:
- Cohort 1: Participants who were relapsed or refractory after prior autologous hematopoietic stem cell transplantation (HSCT):
- Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).
- Were not considered candidates for additional autologous or allogeneic HSCT (a transplant using donor stem cells).
- Cohort 2: Participants who were relapsed or refractory to salvage chemotherapy and had not received prior HSCT:
- Were not considered candidates for autologous or allogeneic HSCT.
- Had received at least one prior systemic therapy regimen for cHL.
- Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\\\[18F\] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.
- Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, indicating full activity or restricted activity but capable of self-care.
- Key
Exclusion
- Participants had nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
- Participants had received prior allogeneic HSCT.
- Participants had received prior therapy targeting immune checkpoint pathways, including programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
- Participants had active autoimmune disease or a history of autoimmune disease with potential to relapse.
- Note: Additional inclusion and exclusion criteria defined in the protocol may have applied.
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04318080
Start Date
August 20 2020
End Date
August 29 2024
Last Update
September 24 2025
Active Locations (4)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2013
2
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920-1511
3
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
4
Monash Health
Clayton, Victoria, Australia, VIC 3168