Status:
TERMINATED
Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma
Lead Sponsor:
BeiGene
Conditions:
Classical Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04486391
Start Date
September 1 2020
End Date
October 13 2025
Last Update
November 14 2025
Active Locations (7)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362000
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000