Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT04318080) | Clinical Trial Compass
CompletedPhase 2
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
United States, Australia46 participantsStarted 2020-08-20
Plain-language 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 treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
✓. Participants had either:
✓. 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).
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.