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

NCT04486391 | Terminated Phase 3

• 2 other identifiers: BGB-A317-314CTR20201517
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (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

  Up to 45 months

Secondary Outcomes (7)

• Duration of Response (DOR) by Investigator

  Up to 45 months

• Overall Response Rate (ORR) by Investigator

  Up to 45 months

• Rate of Complete Response (CR) by Investigator

  Up to 45 months

• Time to Response (TTR) by Investigator

  Up to 45 months

• Overall survival (OS)

  Up to 45 months

Study Arms (2)

Tislelizumab

EXPERIMENTAL

Tislelizumab monotherapy for up to 45 months

Drug: Tislelizumab

Salvage chemotherapy

EXPERIMENTAL

Salvage chemotherapy for up to 45 months

Drug: Salvage Chemotherapy

Interventions

Salvage Chemotherapy DRUG

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)

Salvage chemotherapy

Tislelizumab DRUG

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

Also known as: BGB-A317

Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Quanzhou First Affliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130021, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

tislelizumab

Study Officials

• Xia Zhao, MD

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: December 14, 2020
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (7)