Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (TIRHOL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04318080 |
Recruitment Status :
Recruiting
First Posted : March 23, 2020
Last Update Posted : December 15, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Classical Hodgkin Lymphoma | Drug: Tislelizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma |
Actual Study Start Date : | August 20, 2020 |
Estimated Primary Completion Date : | March 30, 2024 |
Estimated Study Completion Date : | March 30, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Participants with relapsed or refractory Classical Hodgkin Lymphoma (cHL) who have failed to achieve a response or progressed after autologous hematopoietic stem cell transplantation (HSCT)
|
Drug: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)
Other Name: BGB-A317 |
Experimental: Cohort 2
Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT
|
Drug: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)
Other Name: BGB-A317 |
- Overall Response Rate (ORR) [ Time Frame: Up to 30 months ]ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
- Complete Response Rate (CRR) [ Time Frame: Up to 30 months ]Defined as the proportion of patients who achieve the best response of complete response (CR)
- Duration of Response (DOR) [ Time Frame: Up to 30 months ]Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first
- Time to Response (TTR) [ Time Frame: Up to 30 months ]Time from the date of the first dose of tislelizumab to the time the response criteria are first met
- Number of participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 30 days posttreatment (Treatment duration is 30 months) ]
- Number of participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment (Treatment duration is 30 months) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318080
Contact: BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |

Principal Investigator: | Herve Ghesguieres | Lymphoma Study Association |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT04318080 |
Other Study ID Numbers: |
BGB-A317-210 2019-002105-22 ( EudraCT Number ) |
First Posted: | March 23, 2020 Key Record Dates |
Last Update Posted: | December 15, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |