Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Classical Hodgkin Lymphoma Clinical Trial

— TIRHOL  

Official title:

A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04318080
• Other study ID #: BGB-A317-210
• Secondary ID: 2019-002105-22
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 20, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: September 30, 2024
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of relapsed or refractory cHL

2. Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria: Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell transplant (HSCT)

1. Has failed to achieve a response or progressed after autologous HSCT

2. Is not a candidate for additional autologous or allogeneic HSCT Cohort 2: Relapsed or refractory to salvage chemotherapy, and has not received prior autologous or allogeneic HSCT

1. Is not a candidate for autologous or allogeneic HSCT

2. Has received at least 1 prior systemic regimen for cHL

3. Measurable disease defined as = 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is > 1.5 cm in the longest diameter, or = 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter

4. Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma

2. Prior allogeneic hematopoietic stem cell transplantation

3. Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways

4. Active autoimmune disease or history of autoimmune disease that may relapse NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Border Medical Oncology	Albury	New South Wales
Australia	Monash Medical Center	Clayton	Victoria
Australia	Saint Vincent's Hospital Melbourne	Fitzroy	Victoria
Belgium	Institut Jules Bordet	Bruxelles
Belgium	CHU de Liège - Domaine Universitaire du Sart Tilman	Liège
Belgium	CHU UCL Namur - Site Godinne	Yvoir
France	Institut d'Hematologie de Basse-Normandie	Caen
France	Hopital Henri-Mondor	Créteil
France	CHU Dijon Bourgogne	Dijon
France	CHD de Vendee	La Roche-sur-Yon
France	CH de Versailles - Hopital Andre Mignot	Le Chesnay
France	CHRU de Lille- Hôpital Claude Huriez	Lille
France	CHU de Limoges - Hopital Dupuytren	Limoges
France	CHU de Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	Hopital Saint-Louis	Paris
France	CHU de Bordeaux Hopital Haut-Leveque	Pessac
France	CHU Lyon-Sud	Pierre-Bénite
France	Centre Henri-Becquerel	Rouen
France	CHRU de Strasbourg	Strasbourg
France	IUCT Oncopole	Toulouse
France	CHU Brabois	Vandœuvre-lès-Nancy
France	Institut Gustave Roussy- Cancer Campus Grand Paris	Villejuif	Val De Marne
Puerto Rico	Hospital Oncologico-PR Med Ctr	Rio Piedras
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center	Bergen	New Jersey
United States	Memorial Sloan Kettering Cancer Center	Commack	New York
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	University of TN Medical Center	Knoxville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	Monmouth Junction	New Jersey
United States	Memorial Sloan Kettering Cancer Center	Nassau	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Huntsman Cancer Center, University of Utah	Salt Lake City	Utah
United States	Memorial Sloan Kettering Cancer Center	Westchester	New York

Sponsors (2)

Lead Sponsor	Collaborator
BeiGene	Lymphoma Study Association

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)	Up to 30 months
Secondary	Complete Response Rate (CRR)	Defined as the proportion of participants who achieve the best response of complete response (CR)	Up to 30 months
Secondary	Duration of Response (DOR)	Time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first. Only participants who have achieved an overall response will be included in the analysis.	Up to 30 months
Secondary	Time to Response (TTR)	Time from the date of the first dose of tislelizumab to the time the response criteria are first met. Only participants who have achieved an overall response will be included in the analysis.	Up to 30 months
Secondary	Number of participants Experiencing Adverse Events (AEs)		Up to 30 days posttreatment (Treatment duration is 30 months)
Secondary	Number of participants Experiencing Serious Adverse Events (SAEs)		Up to 30 days posttreatment (Treatment duration is 30 months)