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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04318080
Ethics application status
Date submitted
20/03/2020
Date registered
23/03/2020

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 Patients 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 - 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)

Experimental: Cohort 2 - Participants with relapsed or refractory cHL who have received at least 1 prior systemic regimen and are not candidates for autologous or allogeneic HSCT


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)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Complete Response Rate (CRR)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Time to Response (TTR)
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Number of participants Experiencing Adverse Events (AEs)
Timepoint [4] 0 0
Up to 30 days posttreatment (Treatment duration is 30 months)
Secondary outcome [5] 0 0
Number of participants Experiencing Serious Adverse Events (SAEs)
Timepoint [5] 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:

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
Minimum age
18 Years
Maximum age
No limit
Sex
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 , 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.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Center - Clayton
Recruitment hospital [4] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
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
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Belgium
State/province [8] 0 0
Yvoir
Country [9] 0 0
France
State/province [9] 0 0
Val De Marne
Country [10] 0 0
France
State/province [10] 0 0
Caen
Country [11] 0 0
France
State/province [11] 0 0
Créteil
Country [12] 0 0
France
State/province [12] 0 0
Dijon
Country [13] 0 0
France
State/province [13] 0 0
La Roche-sur-Yon
Country [14] 0 0
France
State/province [14] 0 0
Le Chesnay
Country [15] 0 0
France
State/province [15] 0 0
Lille
Country [16] 0 0
France
State/province [16] 0 0
Limoges
Country [17] 0 0
France
State/province [17] 0 0
Montpellier
Country [18] 0 0
France
State/province [18] 0 0
Nantes
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Pessac
Country [21] 0 0
France
State/province [21] 0 0
Pierre-Bénite
Country [22] 0 0
France
State/province [22] 0 0
Rouen
Country [23] 0 0
France
State/province [23] 0 0
Strasbourg
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Vandœuvre-lès-Nancy
Country [26] 0 0
Puerto Rico
State/province [26] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04318080