Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT ID: NCT04318080

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2024-08-29

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 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.

Conditions

Classical Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

200 milligrams (mg) intravenously every 3 weeks (Q3W)

Cohort 2

Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

200 milligrams (mg) intravenously every 3 weeks (Q3W)

Interventions

Tislelizumab

200 milligrams (mg) intravenously every 3 weeks (Q3W)

Intervention Type: DRUG

Other Intervention Names

BGB-A317

Eligibility Criteria

Inclusion Criteria

1. Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).

2. 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):

1. Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).

2. 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:

1. Were not considered candidates for autologous or allogeneic HSCT.

2. Had received at least one prior systemic therapy regimen for cHL.

3. 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.

4. 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

1. Participants had nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.

2. Participants had received prior allogeneic HSCT.

3. 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).

4. Participants had active autoimmune disease or a history of autoimmune disease with potential to relapse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lymphoma Study Association

OTHER

Sponsor Role: collaborator

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herve Ghesguieres

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Monash Health

Clayton, Victoria, Australia

Countries

United States; Australia

References

Ghesquières H, López-Guillermo A, De la Cruz F, et al. Tislelizumab, an anti-PD-1 antibody, in patients with relapsed/refractory classical Hodgkin lymphoma in TIRHOL BGB-A317-210: a prospective multicenter LYSA phase 2 study conducted in Western countries. Blood. 2023;142(Suppl 1):1717. DOI:10.1182/blood-2023-188545

Reference Type: RESULT

Ghesquières H, et al. TIRHOL (BGB-A317-210): International Phase 2 Study in Relapsed/Refractory Classical Hodgkin Lymphoma. Presented at: Congrès de la Société Française d'Hématologie (SFH); March 2024; Paris, France.

Reference Type: RESULT

Ghesquières H, López-Guillermo A, De la Cruz F, et al. Final analysis from the LYSA phase 2 TIRHOL study (BGB-A317-210): tislelizumab in relapsed/refractory classical Hodgkin lymphoma. Presented at: 18th International Conference on Malignant Lymphoma (ICML); June 18-22, 2025; Lugano, Switzerland. https://doi.org/10.1002/hon.70093_130

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002105-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BGB-A317-210

Identifier Type: -

Identifier Source: org_study_id