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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04318080




Registration number
NCT04318080
Ethics application status
Date submitted
20/03/2020
Date registered
23/03/2020
Date last updated
22/04/2021

Titles & IDs
Public title
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Scientific title
A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
Secondary ID [1] 0 0
2019-002105-22
Secondary ID [2] 0 0
BGB-A317-210
Universal Trial Number (UTN)
Trial acronym
TIRHOL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tislelizumab

Experimental: Cohort 1: Tislelizumab Monotherapy Post HSCT - Participants with relapsed or refractory Classical Hodgkin Lymphoma (cHL) who have failed to achieve a response or progressed after autologous hematopoietic stem cell transplantation (HSCT) and failed to achieve a response or progressed after brentuximab vedotin

Experimental: Cohort 2: Tislelizumab Monotherapy Post Chemotherapy - Participants with relapsed or refractory cHL who have received at least 2 prior systemic chemotherapy regimens, and are not candidates for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy (did not achieve a Partial Response (PR) or Complete Response (CR)) and failed to achieve a response or progressed after brentuximab vedotin


Treatment: Drugs: Tislelizumab
200 mg intravenously (IV) every 3 weeks (Q3W)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) - ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Time to Response (TTR) - Time from the date of the first dose of tislelizumab to the time the response criteria are first met
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Number of participants Experiencing Adverse Events (AEs)
Timepoint [3] 0 0
Up to 30 days posttreatment (Treatment duration is 30 months)
Secondary outcome [4] 0 0
Number of participants Experiencing Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Up to 30 days posttreatment (Treatment duration is 30 months)

Eligibility
Key inclusion criteria
Key

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:

i) Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell
transplant (HSCT) and brentuximab vedotin

ii) Cohort 2: Relapsed or refractory to salvage chemotherapy, including brentuximab
vedotin, and has not received prior autologous or allogeneic HSCT

1. Is not a candidate for autologous or allogeneic HSCT due to disease refractory to
salvage chemotherapy (did not achieve a PR or CR)

2. Has received at least 2 prior systemic chemotherapy regimens for cHL and failed
to achieve a response or progressed after brentuximab vedotin

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 or PD-L1, anti-PD-L2, or anti CTLA-4 (cytotoxic
T-lymphocyte-associated protein 4) agent

4. Active autoimmune disease or history of autoimmune disease that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Saint Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Wodonga
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Utah
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles
Country [5] 0 0
Belgium
State/province [5] 0 0
Yvoir
Country [6] 0 0
France
State/province [6] 0 0
Caen
Country [7] 0 0
France
State/province [7] 0 0
Créteil
Country [8] 0 0
France
State/province [8] 0 0
Dijon
Country [9] 0 0
France
State/province [9] 0 0
La Roche-sur-Yon
Country [10] 0 0
France
State/province [10] 0 0
Le Chesnay
Country [11] 0 0
France
State/province [11] 0 0
Lille
Country [12] 0 0
France
State/province [12] 0 0
Limoges
Country [13] 0 0
France
State/province [13] 0 0
Montpellier
Country [14] 0 0
France
State/province [14] 0 0
Nantes
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Pessac
Country [17] 0 0
France
State/province [17] 0 0
Pierre-Bénite
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
France
State/province [19] 0 0
VandÅ“uvre-lès-Nancy
Country [20] 0 0
Puerto Rico
State/province [20] 0 0
Rio Piedras

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lymphoma Study Association
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04318080
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Herve Ghesguieres
Address 0 0
Lymphoma Study Association
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04318080