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Classical Hodgkin LymphomaPhase 2TIRHOLNCT04318080

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

A Phase 2 study testing Tislelizumab in people with Classical Hodgkin Lymphoma, run by BeiGene at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Classical Hodgkin Lymphoma
What is being tested?
Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
4 sitesin 2 countries
Study dates
20 Aug 2020to 29 Aug 2024
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-2013

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920-1511

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

Other trials in United States

Australia1 site

  • Monash Health

    Clayton, Victoria, VIC 3168

Other trials in Australia

About this study

Official title: A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

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.

Being tested
Tislelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

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

Study groups in NCT04318080
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants 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.
Receives: Drug: Tislelizumab
Cohort 2ExperimentalParticipants 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.
Receives: Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.

    Measured: 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.

Secondary outcomes (4)

  1. Complete Response Rate (CRR)

    CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected.

    Measured: 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.

  2. Duration of Response (DOR)

    DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier method.

    Measured: 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.

  3. Time to Response (TTR)

    TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR.

    Measured: 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.

  4. Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported:

    Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade.

    Number of participants with any Grade ≥3 TEAEs: Participants who experienced at least one TEAE that was Grade 3 or higher in severity.

    Number of participants with any SAEs: Participants who experienced at least one serious adverse event, regardless of relationship to study treatment, occurring up to 90 days after the last dose.

    Measured: From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start20 Aug 2020
  3. Primary completion12 Dec 2022
  4. Study completion29 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04318080
Sponsor's protocol ID
BGB-A317-210
Other IDs
2019-002105-22, 2019
Acronym
TIRHOL
Status last verified
Sep 2025
First submitted
20 Mar 2020
Last updated
24 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Publications

  • 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

  • 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.

  • 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

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