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Classical Hodgkin LymphomaPhase 3NCT04486391

Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma

A Phase 3 study testing Tislelizumab and Salvage Chemotherapy in people with Classical Hodgkin Lymphoma, run by BeiGene at 7 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator 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 and Salvage Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
7 sitesChina
Study dates
14 Dec 2020to 13 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and
  • Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or
  • Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate.
  • 2. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 4. Must have adequate organ functions. 5. Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of study drug, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1

Who cannot join

  • Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma.
  • Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug.
  • Prior therapies targeting PD-1 or PD-L1.
  • Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
  • Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
  • Serious acute or chronic infection requiring systemic therapy.
  • Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Randomized Controlled Phase 3 Study of Tislelizumab Monotherapy Versus Salvage Chemotherapy in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator

Being tested
Tislelizumab, Salvage Chemotherapy

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 mg administered via intravenous (IV) infusion once every 3 weeks

  • Salvage ChemotherapyDrug

    Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)

Study groups in NCT04486391
Study groupRoleWhat they receive
TislelizumabExperimentalTislelizumab monotherapy for up to 45 months
Receives: Drug: Tislelizumab
Salvage chemotherapyExperimentalSalvage chemotherapy for up to 45 months
Receives: Drug: Salvage Chemotherapy

What is being measured

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

  1. Progression-free Survival (PFS) by Investigator

    Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first

    Measured: Up to 45 months

Secondary outcomes (7)

  1. Duration of Response (DOR) by Investigator

    The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first

    Measured: Up to 45 months

  2. Overall Response Rate (ORR) by Investigator

    The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)

    Measured: Up to 45 months

  3. Rate of Complete Response (CR) by Investigator

    The proportion of participants who achieves a best overall response of CR

    Measured: Up to 45 months

  4. Time to Response (TTR) by Investigator

    Time from the date of randomization to the time the response criteria are first met

    Measured: Up to 45 months

  5. Overall survival (OS)

    Defined as the time from the date of randomization to the date of death due to any reason

    Measured: Up to 45 months

  6. Number of participants experiencing Adverse Events (AEs)

    Measured: Up to 45 months

  7. Number of participants experiencing Serious Adverse Events (SAEs)

    Measured: Up to 45 months

Timeline

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

  1. First posted24 Jul 2020
  2. Study start14 Dec 2020
  3. Primary completion13 Oct 2025
  4. Study completion13 Oct 2025

Why it stopped: Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04486391
Sponsor's protocol ID
BGB-A317-314
Other IDs
CTR20201517
Status last verified
Feb 2026
First submitted
22 Jul 2020
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab and Salvage Chemotherapy in people with Classical Hodgkin Lymphoma, run by BeiGene at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) by Investigator (time frame: Up to 45 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04486391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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