Back to resultsTislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma
Primary Purpose
Classical Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Salvage Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Classical Hodgkin Lymphoma
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- Beijing Cancer HospitalRecruiting
- Quanzhou First Affliated Hospital of Fujian Medical UniversityRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- Hunan Cancer HospitalRecruiting
- Jilin Cancer HospitalRecruiting
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tislelizumab
Salvage chemotherapy
Arm Description
Tislelizumab monotherapy for up to 45 months
Salvage chemotherapy for up to 45 months
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) by Investigator
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first
Secondary Outcome Measures
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
Overall Response Rate (ORR) by Investigator
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
The proportion of participants who achieves a best overall response of CR
Time to Response (TTR) by Investigator
Time from the date of randomization to the time the response criteria are first met
Overall survival (OS)
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)
Number of participants experiencing Serious Adverse Events (SAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486391
Brief Title
Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 26, 2024 (Anticipated)
Study Completion Date
March 26, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tislelizumab
Arm Type
Experimental
Arm Description
Tislelizumab monotherapy for up to 45 months
Arm Title
Salvage chemotherapy
Arm Type
Experimental
Arm Description
Salvage chemotherapy for up to 45 months
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg administered via intravenous (IV) infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Salvage Chemotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) by Investigator
Description
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first
Time Frame
Up to 45 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) by Investigator
Description
The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first
Time Frame
Up to 45 months
Title
Overall Response Rate (ORR) by Investigator
Description
The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)
Time Frame
Up to 45 months
Title
Rate of Complete Response (CR) by Investigator
Description
The proportion of participants who achieves a best overall response of CR
Time Frame
Up to 45 months
Title
Time to Response (TTR) by Investigator
Description
Time from the date of randomization to the time the response criteria are first met
Time Frame
Up to 45 months
Title
Overall survival (OS)
Description
Defined as the time from the date of randomization to the date of death due to any reason
Time Frame
Up to 45 months
Title
Number of participants experiencing Adverse Events (AEs)
Time Frame
Up to 45 months
Title
Number of participants experiencing Serious Adverse Events (SAEs)
Time Frame
Up to 45 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia Zhao, MD
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Quanzhou First Affliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma
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