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

Classical Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486391
• Other study ID #: BGB-A317-314
• Secondary ID: CTR20201517
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: March 26, 2025

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: 1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: March 26, 2025
• Est. primary completion date: September 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

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

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

2. 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:

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.

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• Tislelizumab
200 mg administered via intravenous (IV) infusion once every 3 weeks
• Salvage Chemotherapy
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)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Quanzhou First Affliated Hospital of Fujian Medical University	Quanzhou	Fujian
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to 45 months
Secondary	Overall Response Rate (ORR) by Investigator	The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)	Up to 45 months
Secondary	Rate of Complete Response (CR) by Investigator	The proportion of participants who achieves a best overall response of CR	Up to 45 months
Secondary	Time to Response (TTR) by Investigator	Time from the date of randomization to the time the response criteria are first met	Up to 45 months
Secondary	Overall survival (OS)	Defined as the time from the date of randomization to the date of death due to any reason	Up to 45 months
Secondary	Number of participants experiencing Adverse Events (AEs)		Up to 45 months
Secondary	Number of participants experiencing Serious Adverse Events (SAEs)		Up to 45 months