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

Phase 3

Active, not recruiting

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Drug: Salvage Chemotherapy; Drug: Tislelizumab

• Registration Number: NCT04486391
• Lead Sponsor: BeiGene

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-24
• Study Start: 2020-09-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and

2. Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or

3. 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.

   3. 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

   Key

Exclusion Criteria

1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma. 2. 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. 3. Prior therapies targeting PD-1 or PD-L1. 4. 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. 5. Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence. 6. Serious acute or chronic infection requiring systemic therapy. 7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salvage chemotherapy	Salvage Chemotherapy	Salvage chemotherapy for up to 45 months
Tislelizumab	Tislelizumab	Tislelizumab monotherapy for up to 45 months

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) by Investigator	Up to 45 months	Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
Time to Response (TTR) by Investigator	Up to 45 months	Time from the date of randomization to the time the response criteria are first met
Overall survival (OS)	Up to 45 months	Defined as the time from the date of randomization to the date of death due to any reason
Number of participants experiencing Adverse Events (AEs)	Up to 45 months
Number of participants experiencing Serious Adverse Events (SAEs)	Up to 45 months
Duration of Response (DOR) by Investigator	Up to 45 months	The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first
Overall Response Rate (ORR) by Investigator	Up to 45 months	The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)
Rate of Complete Response (CR) by Investigator	Up to 45 months	The proportion of participants who achieves a best overall response of CR

Trial Locations

Locations (7)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Quanzhou First Affliated Hospital of Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China